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NCT01410643 · ClinicalTrials.gov registry record · NA

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

A NA study of Obesity, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
92
Enrollment target
1
Study location

NCT01410643: Completed NA study of Obesity, sponsored by University of Alabama at Birmingham.

NCT01410643 is a NA study of Obesity that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 92 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01410643, a NA study of Obesity, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
92 participants
Enrollment target
1
Study location

Study Summary

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 peripubert

Primary Outcome

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 change

Conditions Studied

Interventions

  • OTHER Macronutrient Modification

Study Locations (1)

Alabama

  • UAB - Birmingham

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2011-03
Est. Completion 2015-03
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01410643 record still lists

NCT01410643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Macronutrient Modification is the first listed.

NCT01410643 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT01410643 about?

NCT01410643 is a clinical study titled "Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)". 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...

What is the current status of trial NCT01410643?

This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2011-03. Estimated completion is 2015-03.

What conditions does trial NCT01410643 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT01410643?

The interventions under investigation include: Macronutrient Modification (OTHER).

Who is sponsoring clinical trial NCT01410643?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01410643 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01410643's enrollment target sits among peer trials

92 517th of 1053 higher than 536 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01410643, the US trial registry maintained by the National Library of Medicine. NCT01410643 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.