Acute Effects of Cold-induced Shivering on 24-hour the Glucose Profile in Metabolically Compromis… (NCT05576025) | Clinical Trial Compass
CompletedNot Applicable
Acute Effects of Cold-induced Shivering on 24-hour the Glucose Profile in Metabolically Compromised Populations
Netherlands24 participantsStarted 2022-11-23
Plain-language summary
Type 2 Diabetes Mellitus (T2DM) and its associated comorbidities pose a major health concern worldwide. Although lifestyle strategies, such as exercise and diet-induced weight loss are effective interventions to counteract the development and progression of the disease, its prevalence continues to increase. Therefore, alternative therapeutic strategies are warranted. One such method, which has increasingly been gaining attention, is cold exposure. Previously, investigators have shown that exposing T2DM patients to mild cold (14-16 oC) for 6 hours per day for 10 consecutive days enhanced their insulin sensitivity by \~43%. This remarkable improvement in insulin sensitivity was accompanied by robust GLUT4 translocation in the skeletal muscle of participants, which likely mediated the improvements in insulin-stimulated glucose uptake. Follow-up research suggested that a certain degree of muscle activation/shivering appears to be a prerequisite for the cold-induced enhancement in skeletal muscle insulin-stimulated glucose uptake. In humans however, very little information is available about the effects of shivering on glucose metabolism, especially in metabolically compromised individuals. Therefore, in this study, the aim to investigate the acute effects of (different intensities of) shivering on 24-hour glucose profiles in pre-diabetic individuals as well as in T2DM patients. For that purpose, a focus will be placed on clinically relevant glycaemic parameters by means of continuous glucose monitoring, which is increasingly being used in T2DM management and prevention.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for all subjects:
* to be able to provide signed and dated written informed consent prior to any study specific procedures
* have suitable veins for cannulation or repeated venepuncture
* male, or postmenopausal (at least 1 year post cessation of menses) female
* aged 40 - 75 years
* have stable dietary habits (no weight loss or gain \>5 kg within the past 3 months)
* have no signs of active cardiovascular disease or liver malfunction
* have body mass index (BMI) \>= 27 and \<= 38 kg/m2
Additional inclusion criteria for pre-diabetic subjects:
Pre-diabetes based on one or a combination of the following criteria:
* Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening
* ImpairedFastingGlucose(IFG):Fastingplasmaglucose≥6.1mmol/land≤6.9 mmol/l
* Insulin Resistance: glucose clearance rate ≤ 360 mL/kg/min, as determined using OGIS120
* HbA1c of 5.7-6.4%
Additional inclusion criteria for type 2 Diabetes Mellitus patients:
* being diagnosed with T2DM at least 1.5 years before the start of the study
* have well-controlled diabetes, i.e. HbA1c levels \< 8.5%
* have no signs of active diabetes-related co-morbidities, including active cardiovascular diseases, diabetic foot, polyneuropathy or retinopathy
* diet treatment OR on an oral glucose lowering medication: metformin only or in combination with sulfonylurea agents and/or on stable dose o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24-hour area under the curve (AUC) for glucose
Timeframe: 24-hour period before and after each shivering session