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


- candidate number23703
- NTR NumberNTR5711
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2016
- Secondary IDs153030 MEC
- Public TitleThe long-term effect of 10 days cold in diabetic patients.
- Scientific TitleThe effect of cold acclimation on glucose and lipid metabolism
- ACRONYM
- hypothesisThe beneficial effect of cold acclimation on insulin sensitivity is reproducible and the effect wil sustain for a longer period of time. Besides insulin sensitivity, cold acclimation also has beneficial effects on cardiovascular risk factors in type 2 diabetes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Cold acclimation, Insulin sensitivy, Overweight
- 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- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-feb-2016
- planned closingdate1-jul-2017
- Target number of participants16
- InterventionsCold acclimation by staying ten days in a climate chamber of 16 C
- Primary outcome- Insulin sensitivity as determined by hyperinsulinemic euglycemic clamp.
- Metabolism of triglyceride, cholesterol and lipoproteins after a meal.
- Secondary outcome- 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
- Timepoints- Insulin sensitivity: day 4, 19 and 29
- Lipid metabolism: day 1 and 16
- Endothelial and vascular function: day 1 and 16
- Muscle biopsy: day 4, 19 and 29
- Intrahepatic lipid content: day 4 and 19
- Skin temperature: day 6, 8 and 15
- Thermal sensation and comfort: day 6-15
- Endothelial/inflammatory markers; energy metabolism markers: day 1 and 16; day 4 and 19
- Mean glycosylated hemoglobin A1C: day 83
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marie-Fleur J. Habets
- CONTACT for SCIENTIFIC QUERIES Marie-Fleur J. Habets
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
CVON
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD2-feb-2016 - 25-apr-2016


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