The long-term effect of 10 days cold in diabetic patients.

The effect of cold acclimation on glucose and lipid metabolism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22285

Enrollment

Registered

2016-02-02

Start date

2016-02-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold acclimation Non insulin depended diabetes mellitus Insulin sensitivity Obesitas (BMI 28-35) Cardiovascular risks Lipid metabolism Insulinegevoeligheid Koude acclimatie Overgewicht Diabetes mellitus type 2 Vetmetabolisme cardiovasculair risico

Interventions

Cold acclimation by staying ten days in a climate chamber of 16 °C

Eligibility

Inclusion criteria

Inclusion criteria: - Caucasians - Age: 45 – 70 years - BMI: 28-35 kg/m2 - Gender: male or female - Women should be postmenopausal - Diagnosed with type 2 diabetes at least 1.5 years before the start of the study - Relatively well-controlled type 2 diabetes: HbA1c < 8.5% - Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents) - No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy. - No signs of active liver or kidney malfunction.

Exclusion criteria

Exclusion criteria: - Participate in physical activity more than 2x/week - Unstable body weight (weight gain or loss > 5 kg in the last three months) - Participation in another biomedical study concerning brown adipose tissue within 1 month before the first screening visit - Insulin dependent type 2 diabetes patients - Smoking - Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l

Design outcomes

Primary

Measure	Time frame
- Insulin sensitivity as determined by hyperinsulinemic euglycemic clamp. - Metabolism of triglyceride, cholesterol and lipoproteins after a meal.	—

Secondary

Measure	Time frame
- Endothelial dependent and independent vasodilation (measured with Laser Doppler Flowmetry and iontophoresis) - Arterial stiffness (measured with Pulse Wave Velocity) - Central retinal arterial equivalent (CRAE), central retinal vein equivalent (CRVE) and arteriovenous ratio (AVR) - Muscle biopsy: analysis of insulin signalling and insulin independent pathway causing GLUT4 translocation. Analysis of other relevant markers of energy metabolism. Cell culture to investigate the underlying molecular pathway. Skeletal muscle lipid accumulation (measured by immunofluorescence microscopy). - Intrahepatic lipid content (measured with 1H-MRS) - Skin temperature during cold exposure - HbA1c, endothelial/inflammatory markers and energy metabolism markers - Thermal sensation and comfort	—

Measure

Time frame

- Endothelial dependent and independent vasodilation (measured with Laser Doppler Flowmetry and iontophoresis) - Arterial stiffness (measured with Pulse Wave Velocity) - Central retinal arterial equivalent (CRAE), central retinal vein equivalent (CRVE) and arteriovenous ratio (AVR) - Muscle biopsy: analysis of insulin signalling and insulin independent pathway causing GLUT4 translocation. Analysis of other relevant markers of energy metabolism. Cell culture to investigate the underlying molecular pathway. Skeletal muscle lipid accumulation (measured by immunofluorescence microscopy). - Intrahepatic lipid content (measured with 1H-MRS) - Skin temperature during cold exposure - HbA1c, endothelial/inflammatory markers and energy metabolism markers - Thermal sensation and comfort

—

Contacts

Public ContactMichiel Moonen

Maastricht University

m.moonen@maastrichtuniversity.nl043-43384259

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)