| Trial ID: | L4093 |
| Source ID: | NCT03540758
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| Associated Drug: |
Diazoxide
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| Title: |
Regulation of Endogenous Glucose Production by Central KATP Channels
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Glucose Metabolism Disorders|Glucose, High Blood
|
| Interventions: |
DRUG: Diazoxide|DRUG: Nicotinic acid|DRUG: Placebo
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| Outcome Measures: |
Primary: Change in Endogenous glucose production (EGP) rate, Rates of EGP (a measure of the body's production of sugar) will be measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., placebo, diazoxide, nicotinic acid, nicotinic acid/diazoxide), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Measurement of blood glucose concentrations will either be performed with a Precision Xceed Pro glucometer (for overnight admissions in subjects with T2D) or an Analox glucose analyzer in the study room. Increased EGP is the major cause of fasting hyperglycemia. EGP will be determined by subtracting the rates of glucose infusion from the tracer-derived Rates of glucose appearance (Ra). Rates of change in EGP will be reported in concentration/time and summarized by study arm using basic descriptive statistics., 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration |
|
| Sponsor/Collaborators: |
Sponsor: Meredith Hawkins | Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|American Diabetes Association
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
100
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2018-08-01
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| Completion Date: |
2027-04
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| Results First Posted: |
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| Last Update Posted: |
2025-04-01
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| Locations: |
Albert Einstein College of Medicine, Bronx, New York, 10461, United States
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| URL: |
https://clinicaltrials.gov/show/NCT03540758
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