NCT05576025Completed
Acute Effects of Cold-induced Shivering on 24-hour the Glucose Profile in Metabolically Compromised Populations
Effects of Cold-induced Shivering at Different Intensities on 24-hour Glucose Profiles in Pre-diabetic Individuals and Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 26 Sept 2022
- Start date
- 23 Nov 2022
- Primary completion date
- 28 Nov 2024
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Type 2 diabetes
- NCT number
- NCT05576025
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 23 Nov 2022 to the primary completion date, 28 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participation in a clinical study with an investigational product during the last 3 months or as judged by the investigator
- \- being insulin-dependent and/or using SGLT2 inhibitor medications
Other illness
- uncontrolled hypertension
- \- Type 2 Diabetes Mellitus
Lab values
- having Hb \<8 mmol/L (men), Hb \<7 mmol/l (women)
Other
- not meeting the respective inclusion criteria
- consuming alcohol \>2 servings per day (man) or \>1 servings per day (women)
- not wanting to be informed about unexpected medical findings during the screening
- being engaged in structured exercise \> 2h per week
- smoking
- being cold-acclimated, e.g. having taken daily extended cold baths, working in a refrigerated environment, or practicing regular cold-water swimming/showering within 1 month of starting the study
Who the study is looking for
- 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 of a DPPIV inhibitor treatment for at least the last 3 months
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University, Department of Nutrition and Movement Sciences Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
Related publications
- Acute mild cold exposure with shivering reduces 24 h glucose levels in individuals with type 2 diabetes but not prediabetes.Diabetologia · 2026 · PMID 42474505
This page is information, not medical advice. Discuss any trial with your doctor.