- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406922
Circadian Rhythmicity in Cold-induced Thermogenesis (COLDR)
April 14, 2021 updated by: mrboon, Leiden University Medical Center
The Impact of Circadian Rhythmicity in Cold-induced Thermogenesis in Lean and Obese Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Brown adipose tissue (BAT) recently emerged as a novel player in energy expenditure (EE) in humans as it combusts fatty acids and glucose towards heat.
Human BAT can be activated by sympathetic stimulation resulting from cold exposure or treatment with sympathomimetic drugs.
Short-term acclimation to mild cold was shown to reduce fat mass in obese subjects and decrease peripheral insulin resistance of patients with T2DM.
Recently, in preclinical studies the investigators showed that BAT has a circadian rhythm.
It is currently unknown whether this is also the case in humans.
The investigators postulate that BAT activity should display a circadian rhythm that adapts to changes in circadian behavior, and may determine glucose/lipid levels throughout the day.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leiden, Netherlands, 2333ZA
- Leiden University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Cold exposure in the morning and evening.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cold-induced non-shivering thermogenesis between morning and evening
Time Frame: 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.
|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glucose metabolism (mmol/L)
Time Frame: 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.
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Serum glucose (mmol/L) before and during cold exposure in the morning versus the evening.
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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)
Time Frame: 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.
|
Serum insulin (pmol/l) before and during cold exposure in the morning versus in the evening.
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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.
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Change in lipid metabolism (cholesterol) (mmol/L)
Time Frame: 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.
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Cholesterol (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) in serum (mmol/L).
Before and during cold exposure in the morning and in the evening.
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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.
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Change in lipid metabolism (triglycerides) (mmol/L)
Time Frame: 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.
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Triglycerides, glycerol and free fatty acids in serum (mmol/L).
Before and during cold exposure in the morning and in the evening.
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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.
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Change in markers for sympathetic output
Time Frame: 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.
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Norepinephrine, epinephrine (μM/ml)
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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.
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Skin temperature
Time Frame: Change between morning and evening: measured every 60 seconds during cold exposure on both study days. The time frame comprising both the morning and evening measurement will be 72 hours.
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Wireless iButtons and infrared camera
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Change between morning and evening: measured every 60 seconds during cold exposure on both study days. The time frame comprising both the morning and evening measurement will be 72 hours.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mariette R Boon, MD, PhD, Leiden University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 23, 2019
Primary Completion (ACTUAL)
January 1, 2021
Study Completion (ACTUAL)
January 1, 2021
Study Registration Dates
First Submitted
January 21, 2020
First Submitted That Met QC Criteria
May 24, 2020
First Posted (ACTUAL)
May 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 14, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COLD_RHYTHM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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