Prediabetes, prestage of type 2 diabetes
Conditions
Interventions
A subset of prediabetes individuals (first 10 MIR and 10 LIR subjects enrolled) 
will receive a 4-day Acipimox treatment: 3x 250mg capsules for three days (one 
with breakfast, one with lunch and one with evening snack) and 1x 250mg in the 
morning of the last day.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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:an Oral Glucose Insulin Sensitivity Index < 360 mL/min/m2 and/or disturbed glucose values, defined as:or a fasting blood glucose between 6.1 and 6.9 mmol/L or a 2-h plasma glucose between 7.8 and 11.1 mmol/L after the ingestion of 75g oral glucose. Within this prediabetic group, individuals will be classified as having either a MIR or LIR profile based on the glucose response after the oral glucose tolerance test (OGTT). Criteria for the presence of MIR and LIR will be based on tertiles for these parameters from the DioGenes , CODAM, and Maastricht study.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Liver and muscle glycogen (13C-MRS) - Whole body gluconeogenesis (fractional gluconeogenesis determined by deuterated water x EGP determined by 6,6D2-glucose) - Postprandial glucose uptake measured by [18F]-FDG-PET | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary: - Whole body gluconeogenesis (fractional gluconeogenesis determined by deuterated water x EGP determined by 6,6D2-glucose), upon Acipimox treatment - Glucose tolerance determined by OGTT, upon Acipimox treatment - Liver glycogen (13C-MRS), upon Acipimox treatment Other: - Substrate oxidation (fat and carbohydrate oxidation overnight) - Plasma metabolites related to energy metabolism - Body composition (fat mass/fat free mass) - Dynamic measurements of postprandial changes in water relaxation times (1H-MRS) | — |
Countries
Netherlands
Contacts
Public ContactKHM Roumans
Universiteit Maastricht
Outcome results
None listed