Healthy Overweight/ObeseNCT04516018
Shivering and Glucose Homeostasis
A study testing Cold exposure in people with Healthy Overweight/Obese, run by Maastricht University at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Healthy Overweight/Obese
- What is being tested?
- Cold exposure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Caucasian
- Healthy (as determined by dependent physician based on medical questionnaire)
- Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
- Aged 40 - 75 years at the start of the study
- BMI 27 and 35 kg/m2
- Stable dietary habits (no weight loss or gain >3kg in the past 3 months)
Who cannot join
- - Not meeting all inclusion criteria
- Medication use known to hamper subject's safety during study procedures
- Co-morbidities to which the intervention or program that may pose as a complicating factor
- Subjects diagnosed with cardiovascular diseases or cancer
- Fasting plasma glucose ≥ 7.0 mmol/l
- Haemoglobin < 7.8 mmol/l for women, or < 8.4 mmol/l for men
Show all 13Show fewer
- Previously diagnosed with type 2 diabetes
- Abuse alcohol/drug abuse
- Subjects who do not want to be informed about unexpected medical findings during the screening/study or do not wish that their physician is informed.
- Engagement in structured exercise > 2h per week
- Participation in another biomedical study within 1 month before the first study
- Smoking
- Cold-acclimated, such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prolonged Shivering Thermogenesis on Glucose Homeostasis in Overweight/Obese Humans
The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans.
- Conditions
- Healthy Overweight/Obese
- Being tested
- Cold exposure
- Keywords
- Type 2 diabetes mellitus, Shivering thermogenesis, skeletal muscle
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold exposureOther
Subjects will be exposed to shivering thermogenesis for at least 1 hour for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Cold acclimation arm | Experimental | An oral glucose tolerance test will be performed on day 1 of the study. The next day (day 2), subjects will be exposed to shivering thermogenesis for at least 1 hour. The day after, an oral glucose tolerance test will be performed (day 3). The following 9 days, subjects will be exposed daily to shivering thermogenesis for at least 1 hour (day 4-12). On the last day (day 13), an oral glucose tolerance test will be performed. Receives: Other: Cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve (AUC) of the glucose tolerance test
area under the curve (AUC) of the glucose tolerance test before cold exposure, 1 day after cold exposure and after 9 consecutive days of cold exposure.
Measured: 1 day following cold exposure and following 9 consecutive days of cold exposure
Secondary outcomes (1)
skeletal muscle GLUT4 translocation
Comparison between skeletal muscle GLUT4 translocation, as assessed by wide-field microscopy both before and after cold acclimation
Measured: 1 day following cold exposure and following 9 consecutive days of cold exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Sep 2020
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Overweight/ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter van Marken Lichtenbelt, Prof., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516018
- Sponsor's protocol ID
- NL73487.068.20
- Status last verified
- Jan 2022
- First submitted
- 24 Jul 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sellers AJ, van Beek SMM, Hashim D, Baak R, Pallubinsky H, Moonen-Kornips E, Schaart G, Gemmink A, Jorgensen JA, van de Weijer T, Kalkhoven E, Hooiveld GJ, Kersten S, Hesselink MKC, Schrauwen P, Hoeks J, van Marken Lichtenbelt WD. Cold acclimation with shivering improves metabolic health in adults with overweight or obesity. Nat Metab. 2024 Dec;6(12):2246-2253. doi: 10.1038/s42255-024-01172-y. Epub 2024 Dec 6.
PubMed 39643644
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prolonged Shivering Thermogenesis on Glucose Homeostasis in Overweight/Obese Humans
- ClinicalTrials.gov ID
- NCT04516018
- Acronym / sponsor ID
- NL73487.068.20
- Conditions
- Healthy Overweight/Obese
- Keywords
- Type 2 diabetes mellitus, Shivering thermogenesis, skeletal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design
| Arm | Type | Receives |
|---|---|---|
| Cold acclimation arm | Experimental | Other: Cold exposureAn oral glucose tolerance test will be performed on day 1 of the study. The next day (day 2), subjects will be exposed to shivering thermogenesis for at least 1 hour. The day after, an oral glucose tolerance test will be performed (day 3). The following 9 days, subjects will be exposed daily to shivering thermogenesis for at least 1 hour (day 4-12). On the last day (day 13), an oral glucose tolerance test will be performed. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Caucasian
- Healthy (as determined by dependent physician based on medical questionnaire)
- Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
- Aged 40 - 75 years at the start of the study
Key exclusion criteria (13 listed)
- - Not meeting all inclusion criteria
- Medication use known to hamper subject's safety during study procedures
- Co-morbidities to which the intervention or program that may pose as a complicating factor
- Subjects diagnosed with cardiovascular diseases or cancer
- Fasting plasma glucose ≥ 7.0 mmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold exposureSubjects will be exposed to shivering thermogenesis for at least 1 hour for 10 days | Other | Cold acclimation arm |
Primary outcome
area under the curve (AUC) of the glucose tolerance test
Time frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
area under the curve (AUC) of the glucose tolerance test before cold exposure, 1 day after cold exposure and after 9 consecutive days of cold exposure.
1 secondary outcome
skeletal muscle GLUT4 translocation
Time frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 39643644Sellers AJ, van Beek SMM, Hashim D, Baak R, Pallubinsky H, Moonen-Kornips E, Schaart G, Gemmink A, Jorgensen JA, van de Weijer T, Kalkhoven E, Hooiveld GJ, Kersten S, Hesselink MKC, Schrauwen P, Hoeks J, van Marken Lichtenbelt WD. Cold acclimation with shivering improves metabolic health in adults with overweight or obesity. Nat Metab. 2024 Dec;6(12):2246-2253. doi: 10.1038/s42255-024-01172-y. Epub 2024 Dec 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter van Marken Lichtenbelt, Prof. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold exposure in people with Healthy Overweight/Obese, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve (AUC) of the glucose tolerance test (time frame: 1 day following cold exposure and following 9 consecutive days of cold exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.