Circadian Rhythmicity in Cold-induced Thermogenesis

NCT04406922 | Completed

• 1 other identifier: COLD_RHYTHM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate whether maximum cold-induced non-shivering thermogenesis (e.g. thermogenesis as a consequence of BAT activity) differs between morning and evening.

Conditions

Healthy; Obese; Glucose Intolerance

Keywords

lean; young; healthy; overweight; obese

Outcome Measures

Primary Outcomes (1)

• Change in cold-induced non-shivering thermogenesis between morning and evening

  Thermogenesis is estimated by the change in energy expenditure after cold exposure, measured by indirect calorimetry. This will be measured in the morning and in the evening.

  Change in cold-induced non-shivering thermogenesis between morning (total duration of measurement 120 minutes) and evening (total duration of measurement 120 minutes). The time frame comprising both the morning and evening measurement will be 72 hours.

Secondary Outcomes (6)

• Change in glucose metabolism (mmol/L)

  Change between morning and evening: measured at several timepoints during 3.5 hours. The time frame comprising both the morning and evening measurement will be 72 hours.

• Change in insulin (pmol/l)

  Change between morning and evening: measured at several timepoints during 3.5 hours. The time frame comprising both the morning and evening measurement will be 72 hours.

• Change in lipid metabolism (cholesterol) (mmol/L)

  Change between morning and evening: measured at severaltime points during 3.5 hours. The time frame comprising both the morning and evening measurement will be 72 hours.

• Change in lipid metabolism (triglycerides) (mmol/L)

  Change between morning and evening: measured at severaltime points during 3.5 hours. The time frame comprising both the morning and evening measurement will be 72 hours.

• Change in markers for sympathetic output

  Change between morning and evening: measured before and after cold exposure. The time frame comprising both the morning and evening measurement will be 72 hours.

Study Arms (1)

Intervention group

EXPERIMENTAL

Cold exposure in the morning and evening.

Procedure: Personalized cooling protocol

Interventions

Personalized cooling protocol PROCEDURE

As an intervention, a personalized cooling protocol will be used in order to activate BAT and induce non-shivering thermogenesis. During the cooling procedure, subjects will be exposed to mild cold (approx. 14°C) for 150 min. Since the onset temperature of shivering shows a high interindividual variation, we will use a personal cooling protocol to ensure maximum non-shivering EE (and thus an equal maximum activation of BAT). The right temperature will be determined via a subjective method, e.g. to ask the subject if he or she experiences shivering. The time needed to achieve the right temperature is approximately 30-60 minutes. Then, the stable cooling period of 90 min is started. During this time the subject will be asked every 15 minutes whether he is experiencing shivering. If so, temperature will be increased with 2-3°C so that shivering just stops.

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Dutch white Caucasian males or females
• Age: 18-35 years
• Lean group: BMI ≥ 18 and ≤ 25 kg/m2
• Obese glucose tolerant group: BMI ≥ 30 and ≤ 42 kg/m2 and fasted plasma glucose levels \< 5.5 and/or 2 h after OGTT ≤ 7.8 mM
• Obese impaired glucose tolerant group: BMI ≥ 30 and ≤ 42 kg/m2 and fasted plasma glucose levels ≥ 5.5 and/or 2 h after OGTT between 7.8 and 11.1 mM

You may not qualify if:

• Diabetes mellitus (determined on basis of fasting or OGTT defined by ADA criteria (30)
• Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia)
• Any chronic renal or hepatic disease
• Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers, antidepressants)
• Smoking
• Abuse of alcohol or other substances
• Pregnancy
• Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
• Current participation in another research projects that may influence the current research project
• Clinically relevant abnormalities in clinical chemistry at screening (to be judged by the study physician)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

Location

Related Publications (2)

• Sardjoe Mishre ASD, Straat ME, Martinez-Tellez B, Mendez Gutierrez A, Kooijman S, Boon MR, Dzyubachyk O, Webb A, Rensen PCN, Kan HE. The Infrared Thermography Toolbox: An Open-access Semi-automated Segmentation Tool for Extracting Skin Temperatures in the Thoracic Region including Supraclavicular Brown Adipose Tissue. J Med Syst. 2022 Nov 2;46(12):89. doi: 10.1007/s10916-022-01871-7.

  PMID: 36319877 DERIVED

• Straat ME, Martinez-Tellez B, Sardjoe Mishre A, Verkleij MMA, Kemmeren M, Pelsma ICM, Alcantara JMA, Mendez-Gutierrez A, Kooijman S, Boon MR, Rensen PCN. Cold-Induced Thermogenesis Shows a Diurnal Variation That Unfolds Differently in Males and Females. J Clin Endocrinol Metab. 2022 May 17;107(6):1626-1635. doi: 10.1210/clinem/dgac094.

  PMID: 35176767 DERIVED

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Mariette R Boon, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study design encompasses a single-arm randomized intervention study using cold exposure.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: May 29, 2020
• Study Start: April 23, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)