Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes (COOL Kids)

This study has been completed.
Sponsor:
Collaborators:
Consumer Health Foundation
Jessie Ball DuPont Foundation
Information provided by (Responsible Party):
Nazrat Mirza, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01068197
First received: February 11, 2010
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention Phase
Obesity
Type 2 Diabetes Mellitus
Behavioral: Low Glycemic Load Diet versus Low Fat Diet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Change in insulin sensitivity between the two dietary arms [ Time Frame: at 3-, 12- and 24 months ] [ Designated as safety issue: No ]
  • Change in BMI z-score between the two dietary groups [ Time Frame: 3-, 12-, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body fat mass, lipid assay (LDL cholesterol, TG, FFA) between the two dietary arms [ Time Frame: 3-, 12-, and 24 months ] [ Designated as safety issue: No ]
  • Differences in subjective, hormonal, and metabolic between the two dietary arms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: October 2003
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low glycemic load dietary plan

The subjects and their parents will be given instructions, and specific examples, to lower the glycemic load of their diets by replacing high-GI sources of carbohydrates with low-GI food sources, replacing energy from carbohydrate with energy from protein and fat, and attempt to balance meals and snacks with low-GI carbohydrate, proteins and low-fat food sources. The objective will be to achieve macronutrient composition for the low-GL diet of 45-50% low-GI carbohydrates, 20-25% protein, and 30-35% fat. All subjects will receive sessions on behavior modification, increasing physical activity and reducing sedentary behavior.

At 3 months, subjects will be admitted to the GCRC for a 24 hour period for a meal study. They will be given standardized low-glycemic load diet for dinner, breakfast and lunch, followed by an ad lib snack platter. Their subjective, hormonal and metabolic responses will be serially measured.

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.

Active Comparator: Low fat diet

For the low fat diet, subjects and their parents will be given instructions, and specific examples, to lower the fat content of their diet. The composition of the low-fat diet will be targeted to achieve 55-60% carbohydrates (with no discrimination by their glycemic index), 15-20% protein and 25-30% fat. All recruited children will receive sessions on behavior modification, increasing physical activity and reducing sedentary behavior.

At 3 months, subjects will be admitted to the GCRC for a 24 hour period for a meal study. They will be given standardized high-glycemic load diet for dinner, breakfast and lunch, followed by an ad lib snack platter. Their subjective, hormonal and metabolic responses will be serially measured.

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068197

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Nazrat Mirza
Consumer Health Foundation
Jessie Ball DuPont Foundation
Investigators
Principal Investigator: Nazrat M Mirza, MD, ScD Children's Research Institute
  More Information

No publications provided by Children's Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nazrat Mirza, Associate Professor, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01068197     History of Changes
Other Study ID Numbers: K23RR022227; IRB # 3195
Study First Received: February 11, 2010
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Low Glycemic Load diet
Low Glycemic Index diet
Low Fat diet
Obese Hispanic American children and adolescents
At risk for type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014