Diabetes Mellitus, Type 2MicrobiArNCT05372445
Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention
A study testing Non-intensive intervention and Intensive intervention in people with Diabetes Mellitus, Type 2 and Obesity, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial summary
The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, PreDiabetes
- What is being tested?
- Non-intensive intervention and Intensive intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteArgentina
- Study dates
- 30 May 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects without type 2 diabetes, obesity, prediabetes (glucose intolerance), or metabolic syndrome
- HbA1c less than 42mmol/mol (<5.7%)
- BMI between 18.5 and 24.9
- BMI greater than 30
- Fasting glucose between 110 and 125 mg/dl
- HbA1c between 42 and 47 mmol/mol (5.7% to 6.4%)
Show all 11Show fewer
- BMI greater than 30
- Fasting glucose > 126 mg/dl
- HbA1c > 48mmol/mol (6.5% or higher)
- BMI greater than 30
- Treatment with metformin at therapeutic dose (1500-2000 mg/day) or maximum tolerated dose.
Who cannot join
- Subjects with obesity, pre-diabetes medicated with metformin or another drug for diabetes or obesity
- Subjects with type 2 diabetes medicated with another drug that is not metformin
- Subjects with type 2 diabetes diagnosed over 6 years
- Subjects with type 2 diabetes requiring insulin
- Chronic kidney disease grade greater than 3 (measured by EPI)
- Subjects with type 1 diabetes
Show all 17Show fewer
- Intestinal diseases, Crohn's, ulcerative colitis, celiac disease
- Use of antibiotics in the last 3 months
- Pregnancy, lactation
- Psychiatric disorders
- Eating disorder
- Gastric bypass surgery
- Transplanted people
- Oncological pathology diagnosed less than 5 years
- Subjects who do not wish to sign the informed consent
- Subjects who do not agree to participate in the study over the 2 years follow-up
- Subjects who do not have electronic devices and the internet to hold virtual meetings
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Clínicas "José de San Martín"
Capital Federal, Buenos Aires, C1120AAR
About this study
Official title: MicrobiAr: Characterization and Follow-up of Microbiome and Health Indicators in Obese, Pre-Diabetes and Type 2 Diabetes Cohorts Undergoing a Plant-based Diet and Lifestyle Intervention
The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.
Read the detailed description
The present study has 2 stages, one cross-sectional and the other longitudinal. In the cross-sectional stage, a characterization of a single sampling of 480 people divided into 4 cohorts of 120 people each will be carried out: reference controls, subjects with obesity, with prediabetes and with type 2 diabetes. A clinical history will be made, as long as a 7-day food record and clinical laboratory tests. Anthropometric assessment will be carried out by recording weight, height, waist and hip circumference, determination of waist/hip ratios, as well as taking 4 skinfolds, bicipital, triceps, subscapular and suprailiac, arm and calf measurements and force through a dynamometer. The 480 people will also undergo gut microbiota and microbiome tests from stool samples.
During the longitudinal stage, subjects of each cohort (120 with obesity, 120 with prediabetes and 120 with type 2 diabetes) will be randomly divided into two intervention groups (with 60 subjects each). One group will follow a non-intensive intervention (personalized face-to-face follow-up every 2 months). The other group will follow an intensive intervention (personalized face-to-face follow-up every 3 weeks and a weekly remote group meeting). In both cases, a food plan will be followed based on the recommendations of the nutrition service of the Hospital de Clínicas, Argentina, in accordance with recommendations from the American Diabetes Association (ADA) 2019 guidelines with an emphasis on plant-based diet and whole foods.
Follow-up and nutritional guidance
Groups of 15 subjects from each intervention arm will be led by 3 healthcare professionals. In every case, the group's functions will be:
- Obtain a unique 7 day food-recall from all subjects, and upload the data to "MAR24" platform (for the transversal stage).
- Obtain a 2 day food-recall (including one day from the weekend) from all subjects every two months, and upload the data to "MAR24" platform (for the longitudinal stage).
- Complete a shared spreadsheet with clinical, biochemical and anthropometric parameters of every subject's visits to the hospital.
- Collaborate in Whatsapp unidirectional groups. In the non-intensive arm, the messages will only be to remember patients about their visits to the hospital, while in the intensive arm it will also be about other activities, such as workshops.
- Detect subjects who miss their appointments, to establish personalized contact and apply motivational strategies in order to reduce dropout risk.
To accomplish the mentioned tasks, the group leaders will have support from several students from nutrition careers and healthcare professionals.
Influence of physical activity and exercise
A structured physical exercise protocol will be delivered to all subjects. This protocol includes a warm-up, 3 series of 1 minute of eight different strength exercises, with 2 a minute rest. The objective is to accomplish three sessions per week, which can be done in person and supervised by specialists in the Hospital, or online via video call. Subjects will have to record the amount of achieved repetitions in each series of every exercise already done by each session.
The training volume will be adapted according to the subject's capabilities and progress, with the objective of increasing the number of series and reducing resting time between exercises.
Specific follow-up and support proposals for the intensive intervention
In addition to the already mentioned tasks in the follow-up and nutritional guidance's section, for the intensive intervention subjects, group's functions will also be:
- Collaborate in the assembly and execution of virtual food education workshops;
- Coordinate weekly meetings with the 15 assigned subjects, where adherence should be encouraged during the first 3 months. Then, meetings will be spaced out at a minimum of 15 days to 30 days;
- Contribute to the planning of various activities that seek to maximize adherence to the clinical trial of the entire intensive intervention group;
- Coordinate face-to-face visits for nutritional support every 3 weeks for each subject;
- Monitoring adherence through 48-hour records (1 day a week and 1 day a weekend) using the MAR24 platform. Data will be collected by phone calls or video calls to each subject with a frequency of 1 call per month.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, PreDiabetes
- Being tested
- Non-intensive intervention, Intensive intervention
- Keywords
- microbiota, microbiome, plant-based diet, type 2 diabetes remission, metabolic syndrome, caloric restriction, metabolic pathways
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Prediabetic State, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intensive interventionBehavioural
Also called Group A
After an evaluation of 7 day initial food-recall, subjects will receive counseling in order to improve their dietary habits, according to the American Diabetes Association 2019 Guidelines. The goals of this intervention are (i) achieve a caloric restriction of 500 kcal from their habitual energy intake, (ii) prioritize natural, minimally processed foods with a low glycemic index and glycemic load, (iii) eat lean protein sources, both from plant and animal origin and (iv) gradual increments of fiber intake, to achieve at least the minimum recommendations for the general population.
The frequency of the follow-up appointments will be every 4 weeks, alternating between a clinical control and nutritional one. Therefore, the planned nutritional follow-up frequency will be every 2 months. In these appointments, the objective will be to achieve the mentioned energy intake reduction of 500 kcal, aiming to the nutritional goals previously mentioned, with the aid of the food-recalls.
Intensive interventionBehavioural
Also called Group B
People will have virtual education with food and nutrition coaching workshops, as well as weekly meetings in small groups as a support and follow-up groups. The frequency of the face-to-face follow-up appointments will be every 3 weeks.
The nutritional intervention will emphasize the consumption of mainly minimally processed food from plant origin. A vitamin b12 supplement per week will be provided. This intervention group will have 2 stages. First stage will have a duration of 3 months setting the nutritional bases going to a plant-based diet with basic considerations regarding fiber intake reducing meat consumption, and incorporating protein from vegetable sources, among other considerations. Second stage will progress to higher levels of fiber and others nutritional requeriments in order to intensify the nutritional plant-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | No intervention | People between 30-60 years old, without obesity, prediabetes or type 2 diabetes. The purpose of this group is to characterize gut microbiota and microbiome to set the reference values of the argentinian local population. |
| Obesity Group A | Active comparator | People between 30-60 years old, diagnosed with obesity assigned to the non-intensive intervention. Receives: Behavioral: Non-intensive intervention |
| Obesity Group B | Experimental | People between 30-60 years old, diagnosed with obesity assigned to the intensive intervention. Receives: Behavioral: Intensive intervention |
| Prediabetes Group A | Active comparator | People between 30-60 years old, diagnosed with prediabetes assigned to the non-intensive intervention. Receives: Behavioral: Non-intensive intervention |
| Prediabetes Group B | Experimental | People between 30-60 years old, diagnosed with prediabetes assigned to the intensive intervention. Receives: Behavioral: Intensive intervention |
| Type 2 Diabetes Group A | Active comparator | People between 30-60 years old, diagnosed with type 2 diabetes assigned to the non-intensive intervention. Receives: Behavioral: Non-intensive intervention |
| Type 2 Diabetes Group B | Experimental | People between 30-60 years old, diagnosed with type 2 diabetes assigned to the intensive intervention. Receives: Behavioral: Intensive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvements in people with type 2 diabetes, prediabetes, or obesity
These clinical improvements will be defined as:
- In the group of subjects with type 2 diabetes, remission to non-diabetic stage. Considering remission as measuring HbA1c values lower than 6,5% at least 6 months after beginning the lifestyle intervention and 3 months after cessation of any pharmacotherapy, according to the "Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes", Diabetes Care 2021;44(10):2438-2444.
- In the group of subjects with prediabetes, remission to normal glycemia / HbA1c values. Considering normal glycemia lower than 100 mg/gl and HbA1c lower than 5.7%.
- In the group of overweight-obese subjects, a 10% decrease in weight compared to baseline weight, maintained during the second year of follow-up.
Any of the three possible situations will be considered as a clinical improvement event.
Measured: at 2 years, checked every 6 months
Gut microbiota metabolic pathways changes
Increase in the number of gut microbiota metabolic pathways possibly expressed in subjects of intensive intervention compared to their baseline states and also compared to subjects of the non-intensive intervention. This metric refers to possibly expressed metabolic pathways predicted from shotgun metagenomics analysis related to regulation of inflammatory processes, carcinogenesis, intestinal barrier function, oxidative stress, production of SCFAs, regulation of immune response and inflammation, production of derivative aromatic amino acids, regulation of bile acids (synthesis of derivative metabolites of cholesterol), regulation of the level of phospholipid synthesis (anaerobic metabolism of choline).
Measured: at 2 years, checked every 6 months
Secondary outcomes (3)
Metabolic syndrome regression
Participants with diagnosis of metabolic syndrome at baseline who no longer meet metabolic syndrome criteria, according to those established by the Joint Interim Statement in 2009 (Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009;120:1640 -1645.)
Measured: at 2 years, checked every 6 months
Insulin resistance
Measured by HOMA-IR, HOMA-B or triglyceride: HDL-C ratio.
Measured: at 2 years
Gut microbiota diversity changes
Increase of diversity in gut microbiota observed in subjects of the intensive intervention compared to subjects of the non-intensive intervention and also compared to their baseline states.
Measured: at 2 years, checked every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start30 May 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: Recruitment was discontinued due to Argentina severe socio-economic crisis, which significantly impacted hospital operations and research funding. The loss of financial support prevented further enrollment and coverage of clinical and lab assessments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Collaborators
- Facultad de Ingeniería - Universidad Austral, Instituto de Inmunología, Genética y Metabolismo (INIGEM, CONICET-UBA), Illumina, Inc., Zymo Research, Instituto de Investigación y Desarrollo en Bioingeniería y Bioinformática (IBB, CONICET-UNER)
- Responsible party
- Principal investigator, Juan Pablo Bustamante, National Council of Scientific and Technical Research, Argentina
- Investigators
- Juan Bustamante, PhD, Principal investigator, CONICET ResearcherGustavo Frechtel, PhD, Principal investigator, CONICET Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372445
- Sponsor's protocol ID
- MicrobiAr
- Acronym
- MicrobiAr
- Status last verified
- Mar 2026
- First submitted
- 8 May 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all required data in order to reproduce the publication
Publications
Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PubMed 19805654Riddle MC, Cefalu WT, Evans PH, Gerstein HC, Nauck MA, Oh WK, Rothberg AE, le Roux CW, Rubino F, Schauer P, Taylor R, Twenefour D. Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes. Diabetes Care. 2021 Aug 30;44(10):2438-44. doi: 10.2337/dci21-0034. Online ahead of print.
PubMed 34462270
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicrobiAr: Characterization and Follow-up of Microbiome and Health Indicators in Obese, Pre-Diabetes and Type 2 Diabetes Cohorts Undergoing a Plant-based Diet and Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT05372445
- Acronym / sponsor ID
- MicrobiAr / MicrobiAr
- Conditions
- Diabetes Mellitus, Type 2, Obesity, PreDiabetes
- Keywords
- microbiota, microbiome, plant-based diet, type 2 diabetes remission, metabolic syndrome, caloric restriction, metabolic pathways
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was discontinued due to Argentina severe socio-economic crisis, which significantly impacted hospital operations and research funding. The loss of financial support prevented further enrollment and coverage of clinical and lab assessments
- Enrolment
- 468 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Collaborators
- Facultad de Ingeniería - Universidad Austral, Instituto de Inmunología, Genética y Metabolismo (INIGEM, CONICET-UBA), Illumina, Inc., Zymo Research, Instituto de Investigación y Desarrollo en Bioingeniería y Bioinformática (IBB, CONICET-UNER)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.
Detailed description
The present study has 2 stages, one cross-sectional and the other longitudinal. In the cross-sectional stage, a characterization of a single sampling of 480 people divided into 4 cohorts of 120 people each will be carried out: reference controls, subjects with obesity, with prediabetes and with type 2 diabetes. A clinical history will be made, as long as a 7-day food record and clinical laboratory tests. Anthropometric assessment will be carried out by recording weight, height, waist and hip circumference, determination of waist/hip ratios, as well as taking 4 skinfolds, bicipital, triceps, subscapular and suprailiac, arm and calf measurements and force through a dynamometer. The 480 people will also undergo gut microbiota and microbiome tests from stool samples.
During the longitudinal stage, subjects of each cohort (120 with obesity, 120 with prediabetes and 120 with type 2 diabetes) will be randomly divided into two intervention groups (with 60 subjects each). One group will follow a non-intensive intervention (personalized face-to-face follow-up every 2 months). The other group will follow an intensive intervention (personalized face-to-face follow-up every 3 weeks and a weekly remote group meeting). In both cases, a food plan will be followed based on the recommendations of the nutrition service of the Hospital de Clínicas, Argentina, in accordance with recommendations from the American Diabetes Association (ADA) 2019 guidelines with an emphasis on plant-based diet and whole foods.
Follow-up and nutritional guidance
Groups of 15 subjects from each intervention arm will be led by 3 healthcare professionals. In every case, the group's functions will be:
- Obtain a unique 7 day food-recall from all subjects, and upload the data to "MAR24" platform (for the transversal stage).
- Obtain a 2 day food-recall (including one day from the weekend) from all subjects every two months, and upload the data to "MAR24" platform (for the longitudinal stage).
- Complete a shared spreadsheet with clinical, biochemical and anthropometric parameters of every subject's visits to the hospital.
- Collaborate in Whatsapp unidirectional groups. In the non-intensive arm, the messages will only be to remember patients about their visits to the hospital, while in the intensive arm it will also be about other activities, such as workshops.
- Detect subjects who miss their appointments, to establish personalized contact and apply motivational strategies in order to reduce dropout risk.
To accomplish the mentioned tasks, the group leaders will have support from several students from nutrition careers and healthcare professionals.
Influence of physical activity and exercise
A structured physical exercise protocol will be delivered to all subjects. This protocol includes a warm-up, 3 series of 1 minute of eight different strength exercises, with 2 a minute rest. The objective is to accomplish three sessions per week, which can be done in person and supervised by specialists in the Hospital, or online via video call. Subjects will have to record the amount of achieved repetitions in each series of every exercise already done by each session.
The training volume will be adapted according to the subject's capabilities and progress, with the objective of increasing the number of series and reducing resting time between exercises.
Specific follow-up and support proposals for the intensive intervention
In addition to the already mentioned tasks in the follow-up and nutritional guidance's section, for the intensive intervention subjects, group's functions will also be:
- Collaborate in the assembly and execution of virtual food education workshops;
- Coordinate weekly meetings with the 15 assigned subjects, where adherence should be encouraged during the first 3 months. Then, meetings will be spaced out at a minimum of 15 days to 30 days;
- Contribute to the planning of various activities that seek to maximize adherence to the clinical trial of the entire intensive intervention group;
- Coordinate face-to-face visits for nutritional support every 3 weeks for each subject;
- Monitoring adherence through 48-hour records (1 day a week and 1 day a weekend) using the MAR24 platform. Data will be collected by phone calls or video calls to each subject with a frequency of 1 call per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Reference Group | No intervention | –People between 30-60 years old, without obesity, prediabetes or type 2 diabetes. The purpose of this group is to characterize gut microbiota and microbiome to set the reference values of the argentinian local population. |
| Obesity Group A | Active comparator | Behavioral: Non-intensive interventionPeople between 30-60 years old, diagnosed with obesity assigned to the non-intensive intervention. |
| Obesity Group B | Experimental | Behavioral: Intensive interventionPeople between 30-60 years old, diagnosed with obesity assigned to the intensive intervention. |
| Prediabetes Group A | Active comparator | Behavioral: Non-intensive interventionPeople between 30-60 years old, diagnosed with prediabetes assigned to the non-intensive intervention. |
| Prediabetes Group B | Experimental | Behavioral: Intensive interventionPeople between 30-60 years old, diagnosed with prediabetes assigned to the intensive intervention. |
| Type 2 Diabetes Group A | Active comparator | Behavioral: Non-intensive interventionPeople between 30-60 years old, diagnosed with type 2 diabetes assigned to the non-intensive intervention. |
| Type 2 Diabetes Group B | Experimental | Behavioral: Intensive interventionPeople between 30-60 years old, diagnosed with type 2 diabetes assigned to the intensive intervention. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects without type 2 diabetes, obesity, prediabetes (glucose intolerance), or metabolic syndrome
- HbA1c less than 42mmol/mol (<5.7%)
- BMI between 18.5 and 24.9
- BMI greater than 30
- Fasting glucose between 110 and 125 mg/dl
Key exclusion criteria (17 listed)
- Subjects with obesity, pre-diabetes medicated with metformin or another drug for diabetes or obesity
- Subjects with type 2 diabetes medicated with another drug that is not metformin
- Subjects with type 2 diabetes diagnosed over 6 years
- Subjects with type 2 diabetes requiring insulin
- Chronic kidney disease grade greater than 3 (measured by EPI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-intensive interventionAlso: Group AAfter an evaluation of 7 day initial food-recall, subjects will receive counseling in order to improve their dietary habits, according to the American Diabetes Association 2019 Guidelines. The goals of this intervention are (i) achieve a caloric restriction of 500 kcal from their habitual energy intake, (ii) prioritize natural, minimally processed foods with a low glycemic index and glycemic load, (iii) eat lean protein sources, both from plant and animal origin and (iv) gradual increments of fiber intake, to achieve at least the minimum recommendations for the general population. The frequency of the follow-up appointments will be every 4 weeks, alternating between a clinical control and nutritional one. Therefore, the planned nutritional follow-up frequency will be every 2 months. In these appointments, the objective will be to achieve the mentioned energy intake reduction of 500 kcal, aiming to the nutritional goals previously mentioned, with the aid of the food-recalls. | Behavioural | Obesity Group A, Prediabetes Group A, Type 2 Diabetes Group A |
| Intensive interventionAlso: Group BPeople will have virtual education with food and nutrition coaching workshops, as well as weekly meetings in small groups as a support and follow-up groups. The frequency of the face-to-face follow-up appointments will be every 3 weeks. The nutritional intervention will emphasize the consumption of mainly minimally processed food from plant origin. A vitamin b12 supplement per week will be provided. This intervention group will have 2 stages. First stage will have a duration of 3 months setting the nutritional bases going to a plant-based diet with basic considerations regarding fiber intake reducing meat consumption, and incorporating protein from vegetable sources, among other considerations. Second stage will progress to higher levels of fiber and others nutritional requeriments in order to intensify the nutritional plant-based intervention. | Behavioural | Obesity Group B, Prediabetes Group B, Type 2 Diabetes Group B |
Primary outcome
Clinical improvements in people with type 2 diabetes, prediabetes, or obesity
Time frame: at 2 years, checked every 6 months
These clinical improvements will be defined as: 1. In the group of subjects with type 2 diabetes, remission to non-diabetic stage. Considering remission as measuring HbA1c values lower than 6,5% at least 6 months after beginning the lifestyle intervention and 3 months after cessation of any pharmacotherapy, according to the "Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes", Diabetes Care 2021;44(10):2438-2444. 2. In the group of subjects with prediabetes, remission to normal glycemia / HbA1c values. Considering normal glycemia lower than 100 mg/gl and HbA1c lower than 5.7%. 3. In the group of overweight-obese subjects, a 10% decrease in weight compared to baseline weight, maintained during the second year of follow-up. Any of the three possible situations will be considered as a clinical improvement event.
Gut microbiota metabolic pathways changes
Time frame: at 2 years, checked every 6 months
Increase in the number of gut microbiota metabolic pathways possibly expressed in subjects of intensive intervention compared to their baseline states and also compared to subjects of the non-intensive intervention. This metric refers to possibly expressed metabolic pathways predicted from shotgun metagenomics analysis related to regulation of inflammatory processes, carcinogenesis, intestinal barrier function, oxidative stress, production of SCFAs, regulation of immune response and inflammation, production of derivative aromatic amino acids, regulation of bile acids (synthesis of derivative metabolites of cholesterol), regulation of the level of phospholipid synthesis (anaerobic metabolism of choline).
3 secondary outcomes
Metabolic syndrome regression
Time frame: at 2 years, checked every 6 months
Insulin resistance
Time frame: at 2 years
Gut microbiota diversity changes
Time frame: at 2 years, checked every 6 months
Results and safety
The study was stopped early (reason given: Recruitment was discontinued due to Argentina severe socio-economic crisis, which significantly impacted hospital operations and research funding. The loss of financial support prevented further enrollment and coverage of clinical and lab assessments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 19805654Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
- Background: PubMed 34462270Riddle MC, Cefalu WT, Evans PH, Gerstein HC, Nauck MA, Oh WK, Rothberg AE, le Roux CW, Rubino F, Schauer P, Taylor R, Twenefour D. Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes. Diabetes Care. 2021 Aug 30;44(10):2438-44. doi: 10.2337/dci21-0034. Online ahead of print.
- Individual participant dataSharing planned: Yes. all required data in order to reproduce the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Bustamante, PhD principal investigator
CONICET Researcher
Gustavo Frechtel, PhD principal investigator
CONICET Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-intensive intervention and Intensive intervention in people with Diabetes Mellitus, Type 2 and Obesity, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was discontinued due to Argentina severe socio-economic crisis, which significantly impacted hospital operations and research funding. The loss of financial support prevented further enrollment and coverage of clinical and lab assessments). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvements in people with type 2 diabetes, prediabetes, or obesity (time frame: at 2 years, checked every 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05372445, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.