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Mild heat and insulin sensitivity


- candidate number24009
- NTR NumberNTR5696
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2016
- Secondary IDsNL56876.068.16 
- Public TitleMild heat and insulin sensitivity
- Scientific TitleThe effect of mild heat acclimation on insulin sensitivity and thermophysiology
- ACRONYMHeatIn
- hypothesisWe hypothesize that in pre-diabetic participants (impaired fasting glucose, IFG and/or impaired glucose tolerance, IGT), passive mild heat acclimation (35˚C) will improve insulin signalling and affect heat shock protein 72 expression, which might be involved in the changes in insulin resistance. We furthermore hypothesize that passive mild heat acclimation will alter thermophysiological parameters (energy expenditure, total sweat loss, sweat rate, core body temperature, skin temperature distribution, skin blood flow), cardiovascular parameters and subjective perception of the thermal environment in pre-diabetic participants.
- Healt Condition(s) or Problem(s) studiedPrediabetes
- Inclusion criteriao Men
o Caucasian race
o Age 40-70 years
o BMI between 25 and 30 kg/m2
o Steady dietary habits
o Generally healthy, no medication use that interferes with metabolism. If volunteers need medication (e.g. statin drugs, NSAIDs), it will be reviewed with the dependent physician on individual basis.
o Impaired fasting glucose levels between 6.1 and 7.0mmol/L and/or blood glucose values >7.8-11.1mmol/L 2h after sugar drink consumption during OGTT (screening)
- Exclusion criteriao Fasting plasma glucose >7.0 mmol/L
o Haemoglobin <8.4mmol/L
o No signs of active uncontrolled hypertension, liver of kidney malfunction
o Cardiac problems and cardiovascular diseases, such as angina pectoris, cardiac infarction and arrhythmias
o Any medical condition requiring treatment and/or medication that interferes with investigated parameters. All medical conditions/medications will be reviewed with the dependent physician and in-/exclusion will be decided on individual basis
o Unstable body weight (weight gain or loss >3kg in the past three months)
o Participation in another biomedical study within 1 month prior to screening visit
o Participants, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician will be informed, cannot participate in this study
o Blood donation three month prior to study and three month after finishing study
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate1-apr-2017
- Target number of participants12
- InterventionsThe intervention consists of 10 days (2 half days and 8 full days) of passive mild heat acclimation to 35˚C.
- Primary outcomeo Insulin sensitivity as measured by a 1-step hyperinsulinemic euglycemic clamp
o Insulin signalling and heat shock protein expression in muscle tissue
- Secondary outcomeo Energy expenditure
o Total sweat loss and sweat rate
o Body temperatures (core temperature, skin temperature distribution) and skin blood flow
o Cardiovascular parameters (blood pressure, heart rate, cardiac output)
o Subjective perception of the thermal environment
- Timepointspre and post intervention (days 1, 2 11 and 12)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Wouter Marken Lichtenbelt, van
- CONTACT for SCIENTIFIC QUERIES H. Pallubinsky
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-feb-2016 - 15-apr-2016


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