ObesityNCT01460797
Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
A study testing Glycemic Index Diets and Metformin hydrochloride in people with Obesity, run by Caio Eduardo Gonçalves Reis at 1 site in Brazil.
Trial summary
The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans was not investigated yet. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Glycemic Index Diets and Metformin hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2004to Oct 2006
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were adults (18-50 y), with body mass index (BMI) between 25-35 kg/m².
- Subjects with adequate glycemic and insulinemic response after oral glucose tolerance test: Hypocaloric diet with predominating high glycemic index foods;
- Subjects with altered glycemic response presented at the 120 min point either glycemia <140mg/dL and insulin level >40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods;
- Subjects with impaired glucose tolerance presented at the 120 min point glycemia 140 - 199mg/dL and insulin >40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods and metformin.
Who cannot join
- Smokers
- Pregnant or lactating
- Diagnosis of any metabolic diseases
- Were under medication and therapeutic diet, except oral contraceptive for women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Health Sciences, University of Brasília
Brasília, Federal District, 70910-900
About this study
Official title: Effects of a Caloric Restriction High/Low-glycemic Index Diets and in Combination With Metformin on Glucose Metabolism, Lipid Profile and Body Composition in Overweight/Obese Subjects
The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans was not investigated yet. We hypothesized that the low-GI diet in combination with metformin would elicit greater improvements on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects. This study aims to evaluate the metabolic effects of the adoption of dietary advice to follow caloric restriction high/low GI diets, and low-GI diet associated with metformin on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects.
Read the detailed description
All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement in body composition parameters. In addition, the Low-GI group achieved better results in metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids (Chol, TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on metabolic parameters in overweight or obese type 1 subjects.
- Conditions
- Obesity
- Being tested
- Glycemic Index Diets and Metformin hydrochloride
- Keywords
- Glycemic index, Caloric restriction, Energy intake, Glucose, Lipid Metabolism, Cholesterol, HDL Cholesterol, LDL Cholesterol, Obesity, Metformin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic Index Diets and Metformin hydrochlorideOther
Also called High Glycemic Index, Low Glycemic Index, High Glycemic Index plus Metformin
1g of Metformin hydrochloride a day in High Glycemic Index Diet
| Study group | Role | What they receive |
|---|---|---|
| High Glycemic Index | Other | Hypocaloric diet with predominating high glycemic index foods Receives: Other: Glycemic Index Diets and Metformin hydrochloride |
| Low Glycemic Index | Other | Hypocaloric diet with predominant low glycemic index foods Receives: Other: Glycemic Index Diets and Metformin hydrochloride |
| Low Glycemic Index plus Metformin | Other | Hypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d) Receives: Other: Glycemic Index Diets and Metformin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Metabolism
2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index.
Measured: 0 and 4 months
Secondary outcomes (4)
Lipid Profile
Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio
Measured: 0 and 4 months
Body Composition
Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.
Measured: 0 and 4 months
Clinical Assessment
FSH hormone, urea, creatinine, and uric acid urinary levels
Measured: 0 and 4 months
Food Intake
Energy intake, macronutrients and fiber consumption
Measured: 0 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2004
- Primary completionJun 2005
- Study completionOct 2006
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caio Eduardo Gonçalves Reis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brasilia, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fund to support research of the Federal District, Brazil
- Responsible party
- Sponsor-investigator, Caio Eduardo Gonçalves Reis, University of Brasilia
- Investigators
- Teresa HM da Costa, Ph.D., Study director, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460797
- Sponsor's protocol ID
- Glycemic index and Metformin
- Status last verified
- Oct 2011
- First submitted
- 17 Oct 2011
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Caloric Restriction High/Low-glycemic Index Diets and in Combination With Metformin on Glucose Metabolism, Lipid Profile and Body Composition in Overweight/Obese Subjects
- ClinicalTrials.gov ID
- NCT01460797
- Acronym / sponsor ID
- Glycemic index and Metformin
- Conditions
- Obesity
- Keywords
- Glycemic index, Caloric restriction, Energy intake, Glucose, Lipid Metabolism, Cholesterol, HDL Cholesterol, LDL Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Caio Eduardo Gonçalves ReisUniversity, hospital or other
- Collaborators
- University of Brasilia, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fund to support research of the Federal District, Brazil
- Study start
- Oct 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Oct 2011 (estimated)
- 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 prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans was not investigated yet. We hypothesized that the low-GI diet in combination with metformin would elicit greater improvements on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects. This study aims to evaluate the metabolic effects of the adoption of dietary advice to follow caloric restriction high/low GI diets, and low-GI diet associated with metformin on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects.
Detailed description
All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement in body composition parameters. In addition, the Low-GI group achieved better results in metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids (Chol, TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on metabolic parameters in overweight or obese type 1 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Glycemic Index | Other | Other: Glycemic Index Diets and Metformin hydrochlorideHypocaloric diet with predominating high glycemic index foods |
| Low Glycemic Index | Other | Other: Glycemic Index Diets and Metformin hydrochlorideHypocaloric diet with predominant low glycemic index foods |
| Low Glycemic Index plus Metformin | Other | Other: Glycemic Index Diets and Metformin hydrochlorideHypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants were adults (18-50 y), with body mass index (BMI) between 25-35 kg/m².
- Subjects with adequate glycemic and insulinemic response after oral glucose tolerance test: Hypocaloric diet with predominating high glycemic index foods;
- Subjects with altered glycemic response presented at the 120 min point either glycemia <140mg/dL and insulin level >40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods;
- Subjects with impaired glucose tolerance presented at the 120 min point glycemia 140 - 199mg/dL and insulin >40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods and metformin.
Key exclusion criteria (4 listed)
- Smokers
- Pregnant or lactating
- Diagnosis of any metabolic diseases
- Were under medication and therapeutic diet, except oral contraceptive for women.
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 |
|---|---|---|
| Glycemic Index Diets and Metformin hydrochlorideAlso: High Glycemic Index, Low Glycemic Index, High Glycemic Index plus Metformin1g of Metformin hydrochloride a day in High Glycemic Index Diet | Other | High Glycemic Index, Low Glycemic Index, Low Glycemic Index plus Metformin |
Primary outcome
Glucose Metabolism
Time frame: 0 and 4 months
2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index.
4 secondary outcomes
Lipid Profile
Time frame: 0 and 4 months
Body Composition
Time frame: 0 and 4 months
Clinical Assessment
Time frame: 0 and 4 months
Food Intake
Time frame: 0 and 4 months
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 27 Oct 2011.
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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.
Teresa HM da Costa, Ph.D. study director
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic Index Diets and Metformin hydrochloride in people with Obesity, run by Caio Eduardo Gonçalves Reis at 1 site in Brazil.
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 4 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 27 Oct 2011. 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 Brazil. 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 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?
Glucose Metabolism (time frame: 0 and 4 months). 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 Oct 2011.