Investigating glucose and glycogen metabolism in prediabetes
Investigating Disturbances in Glucose and Glycogen Dynamics in Prediabetes
This study is testing how glucose and glycogen processing works in people with prediabetes compared to healthy individuals, while also looking at how a medication called Acipimox affects these processes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06317142 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the differences in nocturnal and postprandial glucose and glycogen metabolism between individuals with prediabetes and healthy overweight controls. Participants will receive Acipimox to assess its effect on glucose tolerance and fat oxidation by reducing gluconeogenesis. The study will involve screening visits and overnight stays at the university to collect metabolic data. The goal is to better understand how glucose metabolism differs in prediabetes compared to healthy individuals.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 75 with prediabetes, characterized by impaired fasting glucose or impaired glucose tolerance.
Not a fit: Patients with normal glucose metabolism or those who do not meet the age and BMI criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing glucose metabolism in patients with prediabetes.
How similar studies have performed: While similar studies have explored glucose metabolism, this specific approach using Acipimox in prediabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 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) Inclusion Criteria for Prediabetic groups specifically: Impaired Fasting Glucose: 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 Impaired Glucose Tolerance: 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 Exclusion Criteria 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 Exclusion Criteria for Healthy overweight specifically: - Any of the criteria mentioned above to define prediabetes Exclusion Criteria for Prediabetic groups who will undergo acipimox treatment: * Gout * Hypersensitivity to acipimox or to any of the excipients in the tablet * Peptic ulcer/dyspepsia * Medication that interferes with Acipimox (statins, fibrates).
Where this trial is running
Maastricht, Limburg
- Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Vera Schrauwen, PhD — Maastricht University Medical Center
- Study coordinator: Kay Roumans, PhD
- Email: k.roumans@maastrichtuniversity.nl
- Phone: +31433882124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.