The effects of cold-induced shivering at different intensities on 24-hour blood glucose profiles in pre-diabetic individuals and patients with type 2 Diabetes Mellitus

Recruiting

• Conditions: insulin resistance; Type 2 Diabetes; 10018424

• Registration Number: NL-OMON53644
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

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 <= 38 kg/m2
6) Have stable dietary habits (no weight loss or gain > 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 <=
11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening
- Impaired Fasting Glucose (IFG): Fasting plasma glucose >= 6.1 mmol/l and <= 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:
1) Diagnosed with T2DM at least 1.5 years before the start of the study
2) Have well-controlled diabetes at the time of screening, defined as HbA1c
levels < 8.5 %
3) Have no signs of active diabetes-related co-morbidities, including active
cardiovascular diseases, diabetic foot, polyneuropathy or retinopathy
4) Are on a 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

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 < 8 mmol/L (men) or Hb < 7 mmol/L (women)
5) Consuming alcohol > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the 24-hour blood glucose profile expressed as<br /><br>the 24-hour area under the curve (AUC) of interstitial glucose levels assessed<br /><br>by continuous glucose monitoring, whereby the 24-hour AUC before shivering will<br /><br>be compared to 24-h AUC after shivering.<br /><br>In practice, these 24-hour intervals run from ±14:00 (~3 hours after cessation<br /><br>of shivering) to ±14:00 the next day. For the day on which shivering takes<br /><br>place this is day 5-6, for the control day without shivering this is day 1-2 of<br /><br>each study period (P1 and P2). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameter is the 24-hour AUC for interstitial glucose,<br /><br>whereby the mild shivering-induced changes in 24-hour AUC will be compared to<br /><br>moderate shivering-induced changes in 24-hour AUC.<br /><br><br /><br>The 24-hour interval period after both mild and moderate cold will be compared<br /><br>and runs from ±14:00 on day 5 to the same time on day 6.</p><br>