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NCT01851421 · ClinicalTrials.gov registry record

Fat Metabolism and Melanocortin 3 Receptors in African Americans

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Terminated
Registry status
88
Enrollment target

NCT01851421: Clinical Trial study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT01851421 is a clinical trial that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 88 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01851421 was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

TERMINATED
Registry status
88 participants
Enrollment target

Study Summary

Background: \- Melanocortin receptors are proteins in the body that help send messages between body systems. One such receptor, the melanocortin 3 receptor (MC3R), is important for regulating body weight. Differences in MC3R can affect fat metabolism - or how the body handles fat. Some people who have changes in the MC3R genetic code are heavier than those who do not have these changes. These changes are found more often in African Americans. Researchers want to study the MC3R in African American adults to see how these changes may affect fat metabolism. They will look at overweight adults with either the most common genetic code for the MC3R or a rare variant. Objectives: \- To study the role of the MC3R in body weight and fat metabolism. Eligibility: * Healthy African American volunteers between 18 and 55 years of age. * Volunteers must be overweight (body mass index at least 30 kg/m2) but weigh less than 450 lbs. Design: * The study consists of an outpatient screening visit and a 7-day inpatient visit with dietary studies. * Participants will be screened with a physical exam and medical history. Blood samples will be collected. (Participants will need to fast for 10 hours before giving blood samples.) A body scan will be given to determine fat, bone, and muscle content. Participants will complete a 3-day dietary assessment to record their food and drink consumption. They will also have an exercise test to look at heart and lung function. * Participants will have a 7-day inpatient stay. They will have a regular diet for the first 3 days of the study. For the final 4 days, they will have a diet with a higher fat content. * During the inpatient visit, participants will have the following study procedures: * Body measurements * Daily exercise routine * Imaging studies of the body * Measurement of a whole day s energy expenditure (spending one day in metabolic chamber-day 5) * Frequent blood samples * Urine collection for 24 hours (days 3 and 7) * Fat biopsy (c

Primary Outcome

FFA flux by isotopic study

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2013-09-23
Est. Completion 2021-06-28

Why NCT01851421 stopped before completion

NCT01851421 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 88 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01851421 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01851421 about?

NCT01851421 is a clinical study titled "Fat Metabolism and Melanocortin 3 Receptors in African Americans". Background: \- Melanocortin receptors are proteins in the body that help send messages between body systems. One such receptor, the melanocortin 3 receptor (MC3R), is important for regulating body weight. Differences in MC3R can affect fat metabolism - or how the body handles fat. Some people who h...

What is the current status of trial NCT01851421?

This trial is currently terminated. The enrollment target is 88 participants. The study started on 2013-09-23. Estimated completion is 2021-06-28.

Who is sponsoring clinical trial NCT01851421?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01851421, the US trial registry maintained by the National Library of Medicine. NCT01851421 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.