NCT00521729

Metabolism and Thyroid Hormone Changes During Exposure to Cold Temperatures

Completed NA Last updated 16 December 2019

What this trial tests

NA trial testing Exposure to Cold Temperature in Obesity in 160 participants. Completed in 26 June 2018.

Timeline

24 August 2007

Primary endpoint
12 January 2015

26 June 2018

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Primary purpose	other
Enrollment	160
Start date	24 August 2007
Primary completion	12 January 2015
Estimated completion	26 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Exposure to Cold Temperature

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 18 to 60, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine how body metabolism adjusts to small changes in environmental temperature and how it may be related to weight loss.

Healthy, non-obese individuals between 18 and 60 years of age may be eligible for this study. The study consists of one screening visit and one 5-day admission to the NIH Clinical Center for the following procedures:

Diet: Participants follow a proscribed diet consisting of 50% carbohydrates, 20% protein and 30% fat.

DEXA scan to measure body fat. Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body.

Air displacement plethysmography (Bod-Pod) to study fat composition: Subjects sit in a small booth for 10 minutes wearing a swim suit and breathing normally through a tube. This test measures the person s weight and volume precisely.

Metabolic room: Subjects stay 12 hours in a specialized room designed to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out. The room contains a private toilet and sink, treadmill, bed, desk, window, telephone and computer with television and internet access. While in this room, subjects undergo the following:

* Continuous heart rate monitor: Subjects wear an EKG monitor to analyze heart rate variability.
* Spontaneous movements: Subjects wear portable accelerometers at the hip and wrist to measure spontaneous physical movements.
* Continuous temperature monitor: Subjects swallow a small capsule that transmits internal body temperature via miniature, wireless sensors. Adhesive patches placed on the skin monitor external body temperature.
* Blood and urine collections: Subjects collect all of their urine during the 12 hours they are in the metabolic room. Blood samples are taken at specified intervals through a catheter that has been placed in a vein.
* Microdialysis: A small needle is placed into fat tissue just under the skin on the abdomen. A solution containing a minimal amount of ethanol is infused and samples of fluid are collected every 20 minutes as it leaves the fat pad. This helps determine the metabolism level. This procedure starts 30 minutes before entering the metabolic room and continues until the subject leaves the room.

Fat tissue biopsy: A small piece of fat tissue is withdrawn through a needle from under the skin on the abdomen. The sample is used to study fat tissue size and ability to store sugar.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Irisin and FGF21 are cold-induced endocrine activators of brown fat function in humans.
   Lee P, Linderman JD, Smith S, Brychta RJ, et al · · 2014 · cited 628× · PMID 24506871 · DOI 10.1016/j.cmet.2013.12.017
2. Ten putative contributors to the obesity epidemic.
   McAllister EJ, Dhurandhar NV, Keith SW, Aronne LJ, et al · · 2009 · cited 439× · PMID 19960394 · DOI 10.1080/10408390903372599
3. Brown fat activation mediates cold-induced thermogenesis in adult humans in response to a mild decrease in ambient temperature.
   Chen KY, Brychta RJ, Linderman JD, Smith S, et al · · 2013 · cited 136× · PMID 23780370 · DOI 10.1210/jc.2012-4213
4. Mild cold exposure modulates fibroblast growth factor 21 (FGF21) diurnal rhythm in humans: relationship between FGF21 levels, lipolysis, and cold-induced thermogenesis.
   Lee P, Brychta RJ, Linderman J, Smith S, et al · · 2013 · cited 114× · PMID 23150685 · DOI 10.1210/jc.2012-3107
5. Minimal changes in environmental temperature result in a significant increase in energy expenditure and changes in the hormonal homeostasis in healthy adults.
   Celi FS, Brychta RJ, Linderman JD, Butler PW, et al · · 2010 · cited 70× · PMID 20826525 · DOI 10.1530/eje-10-0627
6. Cold-activated brown adipose tissue is an independent predictor of higher bone mineral density in women.
   Lee P, Brychta RJ, Collins MT, Linderman J, et al · · 2013 · cited 51× · PMID 22890364 · DOI 10.1007/s00198-012-2110-y
7. Fibroblast growth factor 21 (FGF21) and bone: is there a relationship in humans?
   Lee P, Linderman J, Smith S, Brychta RJ, et al · · 2013 · cited 44× · PMID 23912560 · DOI 10.1007/s00198-013-2464-9