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Day-night rhythm in muscle metabolism of prediabetic subjects

Day-night rhythm in muscle metabolism of prediabetic subjects - Day-night rhythm in muscle metabolism of prediabetics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46463
Enrollment
60
Registered
2018-03-29
Start date
2018-05-17
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

n.v.t.

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Use of anticoagulants * Fasting plasma glucose * 7.0 mmol/l * Haemoglobin 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

Design outcomes

Primary

MeasureTime frame
The main end-point is a day-night variation/rhythm in skeletal muscle mitochondrial function.

Secondary

MeasureTime frame
Secondary study parameters are day-night variations/rhythms in whole-body energy metabolism, skeletal muscle mRNA and protein levels and liver triglyceride concentration.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)