NCT01460797

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

8 months

First QC Date

October 17, 2011

Last Update Submit

October 25, 2011

Conditions

Obesity

Keywords

Glycemic indexCaloric restrictionEnergy intakeGlucoseLipid MetabolismCholesterolHDL CholesterolLDL CholesterolObesityMetformin

Outcome Measures

Primary Outcomes (1)

  • Glucose Metabolism

    2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index.

    0 and 4 months

Secondary Outcomes (4)

  • Lipid Profile

    0 and 4 months

  • Body Composition

    0 and 4 months

  • Clinical Assessment

    0 and 4 months

  • Food Intake

    0 and 4 months

Study Arms (3)

High Glycemic Index

OTHER

Hypocaloric diet with predominating high glycemic index foods

Other: Glycemic Index Diets and Metformin hydrochloride

Low Glycemic Index

OTHER

Hypocaloric diet with predominant low glycemic index foods

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)

Other: Glycemic Index Diets and Metformin hydrochloride

Interventions

Glycemic Index Diets and Metformin hydrochlorideOTHER

1g of Metformin hydrochloride a day in High Glycemic Index Diet

Also known as: High Glycemic Index, Low Glycemic Index, High Glycemic Index plus Metformin
High Glycemic IndexLow Glycemic IndexLow Glycemic Index plus Metformin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers
  • Pregnant or lactating
  • Diagnosis of any metabolic diseases
  • Were under medication and therapeutic diet, except oral contraceptive for women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Sciences, University of Brasília

Brasília, Federal District, 70910-900, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Teresa HM da Costa, Ph.D.

    University of Brasilia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sub-Investigator

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 27, 2011

Study Start

October 1, 2004

Primary Completion

June 1, 2005

Study Completion

October 1, 2006

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

BR(1)