insulin resistance Type 2 Diabetes
Conditions
Interventions
In a randomised order, the participants will undergo two shivering sessions at
different intensities induced by acute cold exposure. The first intensity will
be at 1.5 times resting metabolic rate (
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for all subjects: 1) Able to provide signed and dated written informed consent prior to any study-specific procedures 2) Have suitable veins for cannulation or repeated venipunture 3) Be men or postmenopausal (at least 1 year post cessation of menses) females 4) Aged between 40 - 75 years at the start of the study 5) Have body mass index (BMI) >= 27 and 5 kg within the past 3 months) 7) Have no signs of active cardiovascular disease or liver malfunction Additional inclusion criteria for prediabetic 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 = 6.1 mmol/l and
Exclusion criteria
Exclusion criteria: For all subjects: 1) Not meeting the respective inclusion criteria 2) Participation in a clinical study with an investigational product during the last 3 months or as judged by the investigator 3) Having uncontrolled hypertension 4) Having Hb 2 servings per day (men) or > 1 serving per day (women) 6) Not wanting to be informed about unexpected medical findings during the screening/ study 7) Being engaged in structured exercise > 2h per week 8) Smoking 9) 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 For pre-diabetic participants: 1) Being previously diagnosed with Type 2 Diabetes Mellitus For Type 2 Diabetes Mellitus patients: 1) Being insulin-dependent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the 24-hour blood glucose profile expressed as the 24-hour area under the curve (AUC) of interstitial glucose levels assessed by continuous glucose monitoring, whereby the 24-hour AUC before shivering will be compared to 24-h AUC after shivering. In practice, these 24-hour intervals run from ±14:00 (~3 hours after cessation of shivering) to ±14:00 the next day. For the day on which shivering takes place this is day 5-6, for the control day without shivering this is day 1-2 of each study period (P1 and P2). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameter is the 24-hour AUC for interstitial glucose, whereby the mild shivering-induced changes in 24-hour AUC will be compared to moderate shivering-induced changes in 24-hour AUC. The 24-hour interval period after both mild and moderate cold will be compared and runs from ±14:00 on day 5 to the same time on day 6. | — |
Countries
Netherlands
Outcome results
None listed