Investigating the impact of KATP channel loss on insulin secretion in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.