Investigating the impact of KATP channel loss on insulin secretion in type 2 diabetes
Hyperglycemia Induced Hyperexcitability: A Novel Role for KATP in the Progression of Type 2 Diabetes
This study is testing how a medication called glipizide affects insulin release in people with type 2 diabetes to see if losing certain channels in the body makes it harder to manage blood sugar, especially in those who are obese.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06830096 on ClinicalTrials.gov |
What this trial studies
This study examines the role of ATP-sensitive potassium (KATP) channels in insulin secretion among individuals with varying glucose tolerance and obesity levels. Participants will ingest a sulfonylurea called glipizide, which inhibits KATP channels, to assess its effects on insulin responses. The study aims to understand how KATP channel loss contributes to insulin secretion failure in type 2 diabetes, potentially linking obesity and diabetes progression. By comparing responses across different groups, the research seeks to clarify the mechanisms behind insulin regulation in these populations.
Who should consider this trial
Good fit: Ideal candidates include individuals with obesity and type 2 diabetes, as well as those with normal glucose tolerance and varying body mass indices.
Not a fit: Patients currently on insulin therapy or with severe diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for managing insulin secretion in type 2 diabetes.
How similar studies have performed: Other studies have indicated the importance of KATP channels in insulin secretion, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lean-normoglycemic group (n=10): BMI ≥18.5 and \<25.0 kg/m², fasting plasma glucose concentration \<95 mg/dl, 2-hr oral glucose tolerance test plasma glucose concentration ≤140-mg/dl, and hemoglobin A1C (HbA1C) ≤5.6%. * Obesity-normoglycemic group (n=10): BMI ≥30 and \<50 kg/m², fasting plasma glucose concentration \<95 mg/dl, 2-hr oral glucose tolerance test plasma glucose concentration ≤140 mg/dl, and hemoglobin A1C (HbA1C) ≤5.6%. * Obesity-impaired fasting glucose group (n=10): BMI ≥30 and \<50 kg/m², fasting plasma glucose concentration 100-125 mg/dl, and 2-hr oral glucose tolerance test plasma glucose concentration \<200 mg/dl. * Obesity-type 2 diabetes group (n=10): BMI ≥30 and \<50 kg/m²; HbA1C 6.5-9.5%, fasting plasma glucose ≥126 mg/dl, 2-hr oral glucose tolerance test plasma glucose concentration ≥200 mg/dl and/or medical history of T2DM and currently using anti-diabetic medications. Exclusion Criteria: * Diabetes therapy with insulin at \>0.5 units/kg/day. * Any change in diabetes medication in previous 3 months. * Unstable weight (\>2% change during the last 2 months before entering the study). * Evidence of significant organ system dysfunction or disease other than obesity and T2D. * Regular use of tobacco products. * Excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women). * Use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study. * Anemia (Hemoglobin \<10.0 g/dL). * Pregnant or breastfeeding. * Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
Where this trial is running
St Louis, Missouri
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Kyle Timmons
- Email: nutritionresearch@wustl.edu
- Phone: 314-273-1879
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.