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NCT01730105 · ClinicalTrials.gov registry record

Chronic Cold Exposure and Energy Metabolism in Humans

A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
7
Enrollment target

NCT01730105: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT01730105 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01730105 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
7 participants
Enrollment target

Study Summary

Background: \- Researchers are studying how metabolism and hormone levels change in response to mild changes in environmental temperature. Changes in metabolism may lessen with time because of hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold exposure may cause weight loss. It is unclear whether exposure to a warmer temperature may cause opposite changes in metabolism. Researchers want to see if longer exposure (1 month) to different temperatures can affect how the body uses energy. Objectives: \- To test changes in energy metabolism in response to different room temperatures. Eligibility: \- Healthy men between 18 and 40 years of age. Design: * The entire study will last for 4 months. It will involve a screening visit and a 4-month inpatient stay at the National Institutes of Health Clinical Center. The inpatient stay will be in a private room at the Metabolic Clinical Research unit. Study participants will be required to stay in the Metabolic Clinical Research unit during the night, but are free to leave during the day. * At the screening visit, participants will have a physical exam and medical history. Blood samples will be collected. A heart function test and diet questionnaire will also be given. * During the first month, the temperature of the private room will be set at to 75.2 degrees F. This will allow the body to become used to the testing environment. * During the second month, the temperature will be set to either a cool (66.2 degrees F) or a warm (80.6 degrees F) temperature. * During the third month, the temperature will return to 75.2 degrees F. * During the fourth month, the temperature will be altered to the opposite temperature to the one set in the second month. * Throughout stay, participants will have daily temperature monitoring and will keep a food diary. Once a week, they will collect all of their urine for 24 hours. Once a month, they will spend 24 hours in a metabolic suite to study their

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2012-11-17
Est. Completion 2018-05-10

What the finished NCT01730105 record still lists

NCT01730105 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.

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

NCT01730105 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01730105 about?

NCT01730105 is a clinical study titled "Chronic Cold Exposure and Energy Metabolism in Humans". Background: \- Researchers are studying how metabolism and hormone levels change in response to mild changes in environmental temperature. Changes in metabolism may lessen with time because of hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold exposure may...

What is the current status of trial NCT01730105?

This trial is currently completed. The enrollment target is 7 participants. The study started on 2012-11-17. Estimated completion is 2018-05-10.

Who is sponsoring clinical trial NCT01730105?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01730105, the US trial registry maintained by the National Library of Medicine. NCT01730105 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.