Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes
Completed · Phase 2/Phase 3
Conditions studied: Obesity, Type 2 Diabetes Mellitus
In brief
The purpose of this study are to: 1. compare two diet plans - a low-glycemic load (low-GL) diet and a low-fat diet. A low-GL diet is expected to keep blood sugar levels more normal, and because the sugar levels stay normal, prevent rapid rises of insulin in the blood. We want to test if Hispanic children at-risk for type 2 diabetes who are given a low-GL diet will have less insulin resistance, will lose more weight, and will decrease their chance of getting type 2 diabetes. 2. compare the effects of Low-GL and high-GL meals on appetitive, hormonal, and metabolic responses of obese Hispanic youth under controlled, standardized conditions. We want to test if children fed low-GL meals would have lower glucose and lower insulin responses, report less hunger and consume less energy than those fed high-GL meals.
Key facts
- Study ID
- NCT01068197
- Run by
- Nazrat Mirza
- People needed
- 113
- Starts
- 2003-10-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2014-09-09
Who can join
Age: 7 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hispanic children aged 7-14 years with BMI >= 95th percentile at risk for T2DM and who are otherwise healthy
- Ethnicity will be by self-identification with the Hispanic or Latino cultural group by the subject's parents and both sets of grandparents.
- At risk for T2DM defined as a positive family history of T2DM plus insulin resistance (fasting hyperinsulinemia ≥ 15 uIU/mL) or impaired glucose tolerance (fasting glucose >110 mg/dl, or 2-hour postglucose challenge >140 mg/dl).
- Only one child per family will be eligible to participate in the study
You may not qualify if…
- pre-existing T2DM
- Cushing syndrome
- untreated hypothyroidism
- pervasive developmental disorder
- severe asthma
- severe untreated depression
- use of medications that promote weight gain or loss
- obesity-associated genetic syndromes (e.g. Prader Willi syndrome)
Where it is running
- Children's National Medical Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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