Actively Recruiting
Hyperglycemia Induced Hyperexcitability: A Novel Role for KATP in the Progression of Type 2 Diabetes
Led by Washington University School of Medicine · Updated on 2025-07-04
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the role of ATP-sensitive potassium (KATP) channel activity in insulin secretion and its changes during the progression of type 2 diabetes. The study focuses on how insulin release, controlled by electrical activity in pancreatic beta cells, may shift from over-secretion to under-secretion as diabetes progresses. It explores the hypothesis that chronic stimulation of beta cells leads to loss of KATP channel function, contributing to the failure of insulin secretion seen in type 2 diabetes. Participants are grouped into four categories based on body mass index and glucose tolerance: lean with normal glucose tolerance, obese with normal glucose tolerance, obese with impaired fasting glucose, and obese with type 2 diabetes. Each participant will ingest a single 10 mg dose of glipizide, a sulfonylurea drug that inhibits KATP channels. Researchers will then measure insulin responses to indirectly assess KATP channel activity across these groups. During the study, participants will undergo assessments including fasting plasma glucose, oral glucose tolerance tests, and hemoglobin A1C measurements to confirm group status. The primary outcome is insulin secretion measured 90 minutes after glipizide ingestion. The study also tracks medical history, medication use, and other health factors. Participation duration and safety monitoring details are determined by the study protocol, and the goal is to better understand insulin secretion patterns in relation to KATP channel activity.
CONDITIONS
Brief Title
Role of KATP Channel Loss in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Lean-normoglycemic group: BMI 18.5 to less than 25.0 kg/m2, fasting plasma glucose less than 95 mg/dl, 2-hour oral glucose tolerance test plasma glucose less than 140 mg/dl, and hemoglobin A1C 5.6% or less
- Obesity-normoglycemic group: BMI 30 to less than 50 kg/m2, fasting plasma glucose less than 95 mg/dl, 2-hour oral glucose tolerance test plasma glucose less than 140 mg/dl, and hemoglobin A1C 5.6% or less
- Obesity-impaired fasting glucose group: BMI 30 to less than 50 kg/m2, fasting plasma glucose 100-125 mg/dl, and 2-hour oral glucose tolerance test plasma glucose less than 200 mg/dl
- Obesity-type 2 diabetes group: BMI 30 to less than 50 kg/m2; hemoglobin A1C 6.5-9.5%, fasting plasma glucose 126 mg/dl or higher, 2-hour oral glucose tolerance test plasma glucose 200 mg/dl or higher and/or medical history of type 2 diabetes and currently using anti-diabetic medications
You will not qualify if you...
- Diabetes therapy with insulin at more than 0.5 units/kg/day
- Any change in diabetes medication in the previous 3 months
- Unstable weight with more than 2% change during the last 2 months before entering the study
- Significant organ system dysfunction or disease other than obesity and type 2 diabetes
- Regular use of tobacco products
- Excessive alcohol consumption (3 or more drinks/day for men, 2 or more drinks/day for women)
- Use of medications affecting study outcomes or increasing risk that cannot be temporarily stopped for the study (e.g., steroids, anticoagulants)
- Anemia with hemoglobin less than 10.0 g/dL
- Pregnant or breastfeeding
- Unable or unwilling to follow the study protocol or deemed inappropriate by the research team, including non-compliance with appointments or medical visits
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants ingest a single 10 mg dose of glipizide to assess insulin secretion and KATP channel activity.
1 visit (in-person) with insulin secretion measured 90 minutes after ingestion
Trial Site Locations
Total: 1 location
1
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
K
Kyle Timmons
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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