Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes

NCT01068197 | Completed Phase 2 DMC

• 2 other identifiers: K23RR022227; IRB # 3195K23RR022227
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study are to:

1. 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. 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

Obesity; Type 2 Diabetes Mellitus

Keywords

Low Glycemic Load diet; Low Glycemic Index diet; Low Fat diet; Obese Hispanic American children and adolescents; At risk for type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Change in insulin sensitivity between the two dietary arms

  at 3-, 12- and 24 months

• Change in BMI z-score between the two dietary groups

  3-, 12-, and 24 months

Secondary Outcomes (2)

• Change in body fat mass, lipid assay (LDL cholesterol, TG, FFA) between the two dietary arms

  3-, 12-, and 24 months

• Differences in subjective, hormonal, and metabolic between the two dietary arms

  3 months

Study Arms (2)

Low glycemic load dietary plan

EXPERIMENTAL

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

Low fat diet

ACTIVE COMPARATOR

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

Interventions

Low Glycemic Load Diet versus Low Fat Diet BEHAVIORAL

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.

Low fat diet; Low glycemic load dietary plan

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Nazrat Mirza: lead
• National Center for Research Resources (NCRR): collaborator
• Consumer Health Foundation: collaborator
• Jessie Ball DuPont Foundation: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

• Mirza NM, Palmer MG, Sinclair KB, McCarter R, He J, Ebbeling CB, Ludwig DS, Yanovski JA. Effects of a low glycemic load or a low-fat dietary intervention on body weight in obese Hispanic American children and adolescents: a randomized controlled trial. Am J Clin Nutr. 2013 Feb;97(2):276-85. doi: 10.3945/ajcn.112.042630. Epub 2012 Dec 19.

  PMID: 23255569 DERIVED

• Mirza NM, Klein CJ, Palmer MG, McCarter R, He J, Ebbeling CB, Ludwig DS, Yanovski JA. Effects of high and low glycemic load meals on energy intake, satiety and hunger in obese Hispanic-American youth. Int J Pediatr Obes. 2011 Jun;6(2-2):e523-31. doi: 10.3109/17477166.2010.544740. Epub 2011 Feb 10.

  PMID: 21309658 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nazrat M Mirza, MD, ScD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: October 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

US (1)