Investigating disturbances in glucose and glycogen dynamics in prediabetes
- Conditions
- Prediabetesprestage of type 2 diabetes10018424
- Registration Number
- NL-OMON53214
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 106
General for all groups:
-Participants are able to provide signed and dated written informed consent
prior to any study specific procedures
- Participants should have suitable veins for cannulation or repeated
venipuncture
- Women are post-menopausal (defined as at least 1 year post cessation of
menses)
- Aged >= 45 and <= 75 years
- Body mass index (BMI) 27 - 38 kg/m2
- Stable dietary habits (no weight loss or gain >5kg in the past 3 months)
- Sedentary lifestyle (not more than 2 hours of sports per week)
Prediabetic groups specifically:
IFG: fasting blood glucose between 6.1 and 6.9 mmol/L and 2-h plasma glucose
after ingestion of 75g oral glucose load below 7.8 mmol/L
IGT: fasting blood glucose below 6.1 mmol/L and 2-h plasma glucose after
ingestion of 75g oral glucose load between 7.8 and 11.1 mmol/L
General for all groups:
- Previous enrolment in a clinical study with an investigational product during
the last 3 months or as judged by the Investigator
- Previously diagnosed with type 2 diabetes
- Patients with congestive heart failure and/or severe renal (eGFR <50mL/min)
and or liver insufficiency or another condition that may interfere with
outcomes measured in this study.
- Any contra-indication MRI scanning
- Alcohol consumption of >2 servings per day for men and >1 servings per day
for woman
- Smoking in the past 6 months
- Medication use that may influence main outcome parameters, specifically the
following types of medication: Type 2 diabetes medication, corticosteroids,
thyroid medication.
- Participation in research or medical examination that included PET scanning
in the last 3 months
Healthy overweight specifically:
- Any of the criteria mentioned above to define prediabetes
Prediabetic groups who will undergo acipimox treatment:
- Gout
- Hypersensitivity to acipimox or to any of the excipients in the tablet
- Peptic ulcer/dyspepsia
- Medication use that interfere with Acipimox (statins, fibrates).
A medical doctor will judge participation eligibility based on the medical
history questionnaire, medication use and fasting blood parameters. If the
medical doctor advises that a volunteer cannot participate, the volunteer will
be excluded from enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Liver and muscle glycogen (13C-MRS)<br /><br>- Whole body gluconeogenesis (fractional gluconeogenesis determined by<br /><br>deuterated water x EGP determined by 6,6D2-glucose)<br /><br>- Postprandial glucose uptake measured by [18F]-FDG-PET</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary:<br /><br>- Whole body gluconeogenesis (fractional gluconeogenesis determined by<br /><br>deuterated water x EGP determined by 6,6D2-glucose), upon Acipimox treatment<br /><br>- Glucose tolerance determined by OGTT, upon Acipimox treatment<br /><br>- Liver glycogen (13C-MRS), upon Acipimox treatment<br /><br><br /><br>Other:<br /><br>- Hepatic acetylcarnitine determined by 1H-MRS as a measure for hepatic<br /><br>gluconeogenesis<br /><br>- Substrate oxidation (fat and carbohydrate oxidation overnight)<br /><br>- Plasma metabolites related to energy metabolism<br /><br>- Body composition (fat mass/fat free mass)<br /><br>- Dynamic measurements of postprandial changes in water relaxation times<br /><br>(1H-MRS)</p><br>