Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01410643
First received: March 30, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

Puberty represents a critical period in terms of metabolic health. Racial differences in insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a female's health later in life. Further, the peripubertal period is likely the period of racial divergence in adiposity noted between European American (EA) and African American (AA) girls. Diet is a major modifiable risk factor. The identification of simple, cost-effective dietary strategies for prevention and management of metabolic disease and excess fat mass accrual during the peripubertal period is a priority. Modification of the diet to affect metabolic and endocrine outcomes with and without weight loss during the pubertal transition represents a novel approach to the pediatric obesity epidemic.

It is likely that the two diets used in this project will have different metabolic effects, including effects on postprandial glycemia, triglyceride concentration, free fatty acid concentration, and satiety. These factors may in turn, affect development of metabolic perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role of carbohydrates on metabolic outcomes, particularly among children, has received little attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for disease progression. Development of a diet that reduces insulin secretion and optimizes metabolic-endocrine health among peripubertal girls will likely reduce obesity and related co-morbidities and future reliance on pharmacologic treatments, even in the absence of weight loss. However, in light of the current trends in pediatric obesity, a safe and effective regimen that also promotes weight loss is needed for the pediatric population.

This proposal is significant in that it will shed light on whether diet composition, as a part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that elevated concentrations of insulin and/or reproductive hormones may contribute to the fat mass accrual in AA and could elevate risks for development of chronic diseases in adulthood. Relatively high postprandial insulin secretion may contribute to the pathogenesis of impaired glucose tolerance and type 2 diabetes due to its facilitation of pancreatic β-cell failure. The results of this study will lead to the development of dietary means for the reduction of insulin, and thereby to the prevention of both pediatric obesity and type 2 diabetes.


Condition Intervention
Obesity
Other: Macronutrient Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Determine if a low-carbohydrate diet (SPEC) is more effective than a standard (STAN) diet in decreasing insulin secretion, increasing insulin sensitivity, and decreasing estradiol concentration among overweight girls 7-11 years. [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]

    This outcome aims to evaluate metabolic and endocrine changes that occur in the absence of weight change.

    Evaluate insulin sensitivity index, insulin secretion, reproductive hormone concentration and body composition (DXA) at baseline and 6-weeks.

    Will measure serum concentrations of insulin (uU/ml) and glucose (mg/dL) following a liquid meal tolerance test (ingestion of carnation instant breakfast) and fat (g), lean (g), bone mass (g) via DXA. We will also evaluate changes in estradiol (pg/ml) , FSH (pg/ml), LH (pg/ml), and testosterone (pg/ml) and lipid profile.


  • Determine if a hypocaloric (weight-loss), SPEC diet results in greater fat loss than a 12-week, hypocaloric, STAN diet among overweight females aged 7-11 years. [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]

    The SPEC diet will be more effective than the STAN diet at promoting fat loss (while preserving bone mass). Evaluate insulin sensitivity, insulin secretion, reproductive hormone status, resting energy expenditure compared to baseline.

    Outcomes will be assessed in serum by measurement of insulin/glucose following a liquid meal tolerance test and whole-body body composition bone marrow adipose tissue volume (cm^3); trabecular bone (g) via DXA, MRI, and pQCT, respectively. We will evaluate changes in estradiol (pg/ml), FSH (pg/ml), LH (pg/ml), testosterone (pg/ml) and lipid profile.



Secondary Outcome Measures:
  • To evaluate the relationship between genetic factors and the physiologic, hormonal, and metabolic response to the two diets, the genetic admixture and genetic association will be evaluated. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    The SPEC diet will be more effective than the STAN diet in decreasing insulin secretion and increasing insulin sensitivity. The SPEC diet will be more effective in reducing insulin, which in turn will reduce estradiol (or the estrogen-androgen ratio) and thereby minimize the relative gain in fat mass.

    Evaluate changes in insulin sensitivity, insulin secretion, reproductive hormone concentration, resting energy expenditure and body composition from baseline and compare results between two arms.



Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reduccd Carbohydrate
42% carbohydrate
Other: Macronutrient Modification
reduced carbohydrate versus standard carbohydrate diet
Active Comparator: STandard Carbohydrate
60% carbohydrate
Other: Macronutrient Modification
reduced carbohydrate versus standard carbohydrate diet

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified as African American or European American
  • Aged 7-11 AND Tanner stage < 3
  • Overweight (BMI percentile 85-97th)
  • Not taking any medication known to affect body composition
  • No prior diagnosis of chronic condition

Exclusion Criteria:

  • Illness that precludes study participation
  • Prescribed medication known to affect body composition
  • Not of EA or AA racial/ethnic group
  • Obese (BMI% > 97th) or normal weight (BMI% < 85th)
  • Reproductively mature as define by Tanner stage > 3
  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: NCT01410643

Locations
United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Krista Casazza, PhD, RD    205-975-4316    kristac@uab.edu   
Contact: Anna L Newton, MS    205-975-3494    newtonal@uab.edu   
Principal Investigator: Krista Casazza, PhD, RD         
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01410643     History of Changes
Other Study ID Numbers: UAB
Study First Received: March 30, 2011
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
puberty
body composition
metabolism
obesity
optimization of body composition
pubertal transition

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014