Glucose and Glycogen Dynamics in Prediabetes

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Glucose and Glycogen Dynamics in Prediabetes," is studying how glucose and glycogen (a form of stored sugar) are processed in people with prediabetes compared to healthy, overweight individuals. Researchers want to find out if there are differences in how these groups handle glucose during the night and after meals. They will also explore whether a medication called Acipimox can help people with prediabetes improve their glucose tolerance, which means how well their body can manage sugar after eating.

To participate, individuals must be aged between 45 and 75, have a body mass index (BMI) between 27 and 38, and have either impaired fasting glucose or impaired glucose tolerance. Participants will need to visit the university for two overnight stays, where they will undergo tests to measure their glucose and glycogen levels. In the study, some prediabetic participants will take Acipimox for four days to see if it helps their body use stored sugar better. This trial is currently recruiting participants and is a great opportunity for those looking to contribute to important research on prediabetes.

Gender

ALL

Eligibility 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).