ObesityDiabEATitNCT06333132
Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)
A study testing Weight loss-induced Diabetes Remission in people with Obesity and Diabetes Mellitus Type 2 in Obese, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Diabetes Mellitus Type 2 in Obese
- What is being tested?
- Weight loss-induced Diabetes Remission
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Feb 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2D for less than 6 years;
- age 18-65 years;
- both genders;
- BMI 27-45 kg/m2;
- HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).
Who cannot join
- type 1 or secondary/genetic diabetes;
- treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;
- weight loss >5% within the previous 6 months;
- eGFR <30 ml/min/1.73m2;
- myocardial infarction within the previous 6 months;
- severe heart failure (NYHA III-IV); eating disorder; substance abuse;
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- severe depression;
- known cancer;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes
The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.
Read the detailed description
Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:
- measurement of fasting glucose and glycated hemoglobin
- Indirect calorimetry
- oral glucose tolerance test
- intravenous glucose tolerance test
- quality of life and diet-related questionnaires
- 72-hour food records
At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.
- Conditions
- Obesity, Diabetes Mellitus Type 2 in Obese
- Being tested
- Weight loss-induced Diabetes Remission
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss-induced Diabetes RemissionBehavioural
Patients will undergo a dietary intervention plus drugs (if needed) with the purpose to obtain a 10% (or at least 10 kg) body weight reduction to achieve diabetes remission
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects with type 2 diabetes mellitus | Experimental | Individualized weight-loss nutritional intervention Receives: Behavioral: Weight loss-induced Diabetes Remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission
The investigators will test whether diabetes remission obtained after 10% weight-loss, induced by an intensive nutritional intervention, is associated with an improvement of the incretin effect from baseline.
Diabetes remission will be defined according to the latest international consensus as an HbA1c <48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy.
The restoration of the incretin effect will be assessed by measuring both incretin levels and estimated incretin mediated insulin secretion before and after achieving the weight loss during an Oral Glucose Tolerance Test followed by an intravenous Glucose Tolerance Test.
Measured: 12 weeks
Secondary outcomes (1)
Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months
Diabetes remission will be defined according to the latest international consensus as an HbA1c <48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy.
Thus, diabetes remission will be assessed after the end of the intervention phase (V1). Participants who will achieve diabetes remission at V1 will be monitored by measuring HbA1c for the next 6 months at 3-month intervals (V2 and V3).
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Domenico Tricò, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333132
- Sponsor's protocol ID
- DiabEAT.it
- Acronym
- DiabEATit
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06333132
- Acronym / sponsor ID
- DiabEATit / DiabEAT.it
- Conditions
- Obesity, Diabetes Mellitus Type 2 in Obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 27 Mar 2024 (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 goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.
Detailed description
Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:
- measurement of fasting glucose and glycated hemoglobin
- Indirect calorimetry
- oral glucose tolerance test
- intravenous glucose tolerance test
- quality of life and diet-related questionnaires
- 72-hour food records
At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese subjects with type 2 diabetes mellitus | Experimental | Behavioral: Weight loss-induced Diabetes RemissionIndividualized weight-loss nutritional intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T2D for less than 6 years;
- age 18-65 years;
- both genders;
- BMI 27-45 kg/m2;
- HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).
Key exclusion criteria (9 listed)
- type 1 or secondary/genetic diabetes;
- treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;
- weight loss >5% within the previous 6 months;
- eGFR <30 ml/min/1.73m2;
- myocardial infarction within the previous 6 months;
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 |
|---|---|---|
| Weight loss-induced Diabetes RemissionPatients will undergo a dietary intervention plus drugs (if needed) with the purpose to obtain a 10% (or at least 10 kg) body weight reduction to achieve diabetes remission | Behavioural | Obese subjects with type 2 diabetes mellitus |
Primary outcome
Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission
Time frame: 12 weeks
The investigators will test whether diabetes remission obtained after 10% weight-loss, induced by an intensive nutritional intervention, is associated with an improvement of the incretin effect from baseline. Diabetes remission will be defined according to the latest international consensus as an HbA1c <48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy. The restoration of the incretin effect will be assessed by measuring both incretin levels and estimated incretin mediated insulin secretion before and after achieving the weight loss during an Oral Glucose Tolerance Test followed by an intravenous Glucose Tolerance Test.
1 secondary outcome
Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Domenico Tricò, MD, PhD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss-induced Diabetes Remission in people with Obesity and Diabetes Mellitus Type 2 in Obese, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico Tricò, MD, PhD (050993640, d.trico@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2024.