Exercise to restore 24h rhythmicity in substrate metabolism of prediabetes subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

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

• Fasting plasma glucose >= 7.0 mmol/l
• Haemoglobin < 7.8 mmol/l
• In case of an abnormal ECG in rest: this will be discussed with the
responsible
medical doctor
• 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
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: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is 24h rhythmicity in substrate metabolism including<br /><br>whole-body energy metabolism (energy expenditure, respiratory quotient). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints refer to 24h blood profile of glucose, insulin, free<br /><br>fatty acids and triglycerides as well as skeletal muscle clock gene expression<br /><br>and mitochondrial respiration. In addition, 24h rhythmicity in core body<br /><br>temperature, salivary melatonin and cortisol and the 24h profile of mRNA and<br /><br>protein levels in peripheral blood mononuclear cells (PBMC*s) involved in the<br /><br>molecular clock.</p><br>