Effects of cold exposure on glucose levels in people with metabolic issues
Effects of Cold-induced Shivering at Different Intensities on 24-hour Glucose Profiles in Pre-diabetic Individuals and Patients With Type 2 Diabetes Mellitus
This study is testing if being exposed to mild cold temperatures for eight days can help people with Type 2 diabetes and pre-diabetes lower their blood sugar levels and improve how their bodies use insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05576025 on ClinicalTrials.gov |
What this trial studies
This study investigates how cold-induced shivering affects glucose profiles over 24 hours in individuals with Type 2 Diabetes Mellitus and pre-diabetes. Participants will undergo a series of assessments, including blood pressure measurements and glucose tolerance tests, before being exposed to mild cold temperatures for eight days. The primary goal is to determine if this cold exposure can improve insulin sensitivity and lower glucose levels in these populations. The study will recruit participants from the Maastricht area through various advertising methods.
Who should consider this trial
Good fit: Ideal candidates are males or postmenopausal females aged 40-75 with a BMI between 27 and 38 who have stable dietary habits and meet specific criteria for pre-diabetes or Type 2 Diabetes Mellitus.
Not a fit: Patients with active cardiovascular disease, liver malfunction, or those outside the specified age and BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel lifestyle intervention to improve glucose control in patients with metabolic disorders.
How similar studies have performed: Previous studies have shown promising results with cold exposure improving insulin sensitivity, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 of a DPPIV inhibitor treatment for at least the last 3 months Exclusion Criteria: * not meeting the respective inclusion criteria * participation in a clinical study with an investigational product during the last 3 months or as judged by the investigator * uncontrolled hypertension * having Hb \<8 mmol/L (men), Hb \<7 mmol/l (women) * 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 Exclusion criteria specific for pre-diabetic subjects: - Type 2 Diabetes Mellitus Exclusion criteria specific for type 2 Diabetes Mellitus patients: - being insulin-dependent and/or using SGLT2 inhibitor medications
Where this trial is running
Maastricht, Limburg
- Maastricht University, Department of Nutrition and Movement Sciences — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joris Hoeks — Maastricht University
- Study coordinator: Dzhansel Hashim
- Email: dzhansel.hashim@maastrichtuniversity.nl
- Phone: 0433881587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.