Day-night rhythm in muscle metabolism of prediabetic subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

* Caucasian
* Healthy (as determined by dependent physician based on medical questionnaire)
* Male
* Age: 40-75
* Overweight: BMI 25 * 35 kg/m2
* Prediabetic based on one or a combination of the following criteria:
o 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.
o Impaired Fasting Glucose (IFG): Fasting plasma glucose * 6.1 mmol/l and * 6.9 mmol/l.
o Insulin Resistance: glucose clearance rate * 360 ml/kg/min, as determined using OGIS120.
o HbA1c of 5.7*6.4%.;* Regular sleeping time (normally 7 * 9h daily)
* Stable dietary habits: no weight gain or loss > 3kg in the last three months

Exclusion Criteria

* Use of anticoagulants
* Fasting plasma glucose * 7.0 mmol/l
* Haemoglobin < 7.8 mmol/l
* Previously diagnosed with type 2 diabetes
* Any medical condition and/or medication that might interfere with the investigated parameters as judged by study physician.
* Current alcohol consumption > 20 grams alcohol/day
* Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, 1 month prior to the screening visit
* Any contra-indication to Magnetic Resonance Imaging (MRI) scanning:
o Any implant or prosthesis that is contra-indicated for MRI (e.g. cardiac pacemaker, defibrillator, neural stimulator and other)
o Metal containing foreign bodies in the eye or brain
o Any other metal containing objects contra-indicated for MRI scanning (e.g. certain prosthetic limbs, certain tattoos or certain permanent eyeliner*)
o Claustrophobia
o Epilepsy
* Any contra-indication to the Equivital telemetric pill:
o Known or suspected obstructive disease of the gastrointestinal tract
o History of disorders or impairment of the gag reflex
o Previous gastrointestinal surgery
o Felinization of the esophagus
o Hypomotility disorders of the gastro-intestinal tract
* Implanted electromedical device
* Extreme early bird or extreme night person (score *30 or *70 on MEQ-SA questionnaire, document F1-2)
* Heavily varying sleep-wake rhythm
* Nightshiftwork during last 3 months
* Travel across > 1 time zone in the last 3 months
* Engagement in exercise > 2 hours total per week
* Significant food allergies/intolerance (seriously hampering study meals)
* Participation in another biomedical study within 1 month before the first study visit
* Using > 400mg caffeine daily (more than 4 coffee or energy drink)
* Smoking
* Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator*s opinion interfere with the study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main end-point is a day-night variation/rhythm in skeletal muscle<br /><br>mitochondrial function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are day-night variations/rhythms in whole-body<br /><br>energy metabolism, skeletal muscle mRNA and protein levels and liver<br /><br>triglyceride concentration.</p><br>