Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes
NCT01068197 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2014-09-09
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Low Glycemic Load Diet versus Low Fat Diet
We propose a randomized controlled clinical trial to evaluate the effectiveness of a low-glycemic load diet versus low-fat diet on insulin sensitivity, body composition, and other hormonal and biochemical measures. The culturally competent and family-based Intervention program has a dietary experimental component (low-glycemic load versus low-fat diet), as well as elements of physical activity, reduction in sedentary behavior and behavior modification. The nutrition training sessions are divided into 12 modules taught over a 12-week course. Care has been taken to make the content and intensity of the low-fat and low-glycemic load programs comparable. Both treatments include 12 weekly sessions, followed by nine monthly, and four 3-monthly sessions. Participants are obese (BMI ≥95th percentile for age and sex) Hispanic American children ages 7-14 years.
Sponsors & Collaborators
-
National Center for Research Resources (NCRR)
collaborator NIH -
Consumer Health Foundation
collaborator UNKNOWN -
Jessie Ball DuPont Foundation
collaborator UNKNOWN -
Nazrat Mirza
lead OTHER
Principal Investigators
-
Nazrat M Mirza, MD, ScD · Children's National Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Primary Completion
- 2010-05-31
- Completion
- 2010-05-31
Countries
- United States
Study Locations
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