Diabetes Mellitus, Type 2LGIMNCT03165877
Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy
A study testing Low-glycemic index in people with Diabetes Mellitus, Type 2, run by Universidad de Valparaiso.
Trial summary
To compare the effect of low-glycemic index versus control lunches and dinners intake on indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2 diabetes under metformin therapy. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Low-glycemic index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2016to 13 Oct 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjets with type 2 diabetes mellitus diagnosis under metformin therapy.
- Female sex.
- Aged 30 to 65 years.
- Body Mass Index (BMI) 22 to 34.9 kg / m2.
Who cannot join
- Women with insulin-releasing drugs or insulin treatment.
- Patients with diabetic nephropathy, retinopathy, chronic kidney disease, stroke.
- Subjects with hypothyroidism without treatment.
- Individuals with food allergies or intolerances.
- Women who present an intake of ≥20 g of alcohol per day quantified through a closed consumption frequency survey.
- Patients with previously diagnosed hepatitis, hepatic cirrhosis or liver cancer.
About this study
Official title: Effect of Low-glycemic Index Lunches and Dinners Intake on Indicators of Satiety, Metabolic Parameters and Liver Steatosis Degree on Women With Type 2 Diabetes Under Metformin Therapy: Controlled Clinical Trial
To compare the effect of low-glycemic index versus control lunches and dinners intake on indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2 diabetes under metformin therapy.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Low-glycemic index, Control
- Keywords
- GLYCEMIC INDEX, NAFLD, METABOLIC PARAMETERS, SATIETY
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-glycemic indexOther
Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.
ControlOther
Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Low-glycemic index | Experimental | Low-glycemic index lunches and dinners (<55%) Receives: Other: Low-glycemic index |
| Control | Active comparator | Medium/high glycemic index lunches and dinners (>60%) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Fasting glycemia at 12 weeks
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Postprandial glycemia
Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks
Measured: up to 12 weeks
Change from Baseline Glycosylated hemoglobin at 12 weeks
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline Triglycerides at 12 weeks
Triglycerides (mg/dL) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline Total cholesterol/HDL ratio at 12 weeks
Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline HDL cholesterol at 12 weeks
HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline Total cholesterol at 12 weeks
Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline LDL cholesterol at 12 weeks
LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks
High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Measured: up to 12 weeks
Change from Baseline Liver steatosis degree at 12 weeks
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
Measured: up to 12 weeks
Subjective satiety
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
Measured: 7 days
Objective satiety
24-hour recall was applied the same 7 days as the VAS to each subject
Measured: 7 days
Secondary outcomes (5)
Body mass index (BMI)
Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.
Measured: up to 12 weeks
Waist circumference
Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.
Measured: up to 12 weeks
Alcohol intake
Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.
Measured: up to 12 weeks
Physical activity
Physical activity was measured at Baseline, 4, 8 and 12 weeks.
Measured: up to 12 weeks
Adherence to treatment
The percentage of adherence to treatment was measured through a daily survey for 12 weeks. It is the calculation of compliance with planned meals intake (number of lunches and dinners eaten / total number of lunches and dinners of the study x 100).
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start31 May 2016
- Primary completion13 Oct 2016
- Study completion13 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Vega Soto, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165877
- Sponsor's protocol ID
- 035-2013
- Acronym
- LGIM
- Status last verified
- May 2017
- First submitted
- 20 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-glycemic Index Lunches and Dinners Intake on Indicators of Satiety, Metabolic Parameters and Liver Steatosis Degree on Women With Type 2 Diabetes Under Metformin Therapy: Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03165877
- Acronym / sponsor ID
- LGIM / 035-2013
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GLYCEMIC INDEX, NAFLD, METABOLIC PARAMETERS, SATIETY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 24 May 2017 (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.
To compare the effect of low-glycemic index versus control lunches and dinners intake on indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2 diabetes under metformin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-glycemic index | Experimental | Other: Low-glycemic indexLow-glycemic index lunches and dinners (<55%) |
| Control | Active comparator | Other: ControlMedium/high glycemic index lunches and dinners (>60%) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjets with type 2 diabetes mellitus diagnosis under metformin therapy.
- Female sex.
- Aged 30 to 65 years.
- Body Mass Index (BMI) 22 to 34.9 kg / m2.
Key exclusion criteria (6 listed)
- Women with insulin-releasing drugs or insulin treatment.
- Patients with diabetic nephropathy, retinopathy, chronic kidney disease, stroke.
- Subjects with hypothyroidism without treatment.
- Individuals with food allergies or intolerances.
- Women who present an intake of ≥20 g of alcohol per day quantified through a closed consumption frequency survey.
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 |
|---|---|---|
| Low-glycemic indexSubjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively. | Other | Low-glycemic index |
| ControlSubjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively. | Other | Control |
Primary outcome
Change from Baseline Fasting glycemia at 12 weeks
Time frame: up to 12 weeks
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
Postprandial glycemia
Time frame: up to 12 weeks
Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks
Change from Baseline Glycosylated hemoglobin at 12 weeks
Time frame: up to 12 weeks
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
Change from Baseline Triglycerides at 12 weeks
Time frame: up to 12 weeks
Triglycerides (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Total cholesterol/HDL ratio at 12 weeks
Time frame: up to 12 weeks
Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks
Change from Baseline HDL cholesterol at 12 weeks
Time frame: up to 12 weeks
HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Total cholesterol at 12 weeks
Time frame: up to 12 weeks
Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline LDL cholesterol at 12 weeks
Time frame: up to 12 weeks
LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks
Time frame: up to 12 weeks
High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks
Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
Time frame: up to 12 weeks
Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
Time frame: up to 12 weeks
Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Change from Baseline Liver steatosis degree at 12 weeks
Time frame: up to 12 weeks
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
Subjective satiety
Time frame: 7 days
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
Objective satiety
Time frame: 7 days
24-hour recall was applied the same 7 days as the VAS to each subject
5 secondary outcomes
Body mass index (BMI)
Time frame: up to 12 weeks
Waist circumference
Time frame: up to 12 weeks
Alcohol intake
Time frame: up to 12 weeks
Physical activity
Time frame: up to 12 weeks
Adherence to treatment
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low-glycemic index in people with Diabetes Mellitus, Type 2, run by Universidad de Valparaiso.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Fasting glycemia at 12 weeks (time frame: up to 12 weeks). The study lists 14 primary outcomes in all. 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 24 May 2017.