| Trial ID: | L4693 |
| Source ID: | NCT02971202
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| Associated Drug: |
Hyperinsulinemic, Euglycemic Clamp
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| Title: |
Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02971202/results
|
| Conditions: |
Type 1 Diabetes Mellitus|Maturity-Onset Diabetes of the Young, Type 2|MODY2|Insulin Resistance
|
| Interventions: |
DRUG: Hyperinsulinemic, euglycemic clamp|DRUG: 20% dextrose
|
| Outcome Measures: |
Primary: Whole-body Glucose Utilization (Rd), The primary outcome is the degree to which Rd (determined using isotopic glucose tracer techniques) during maximal insulin stimulation differs between cohorts., End of clamp study (the study will last 8 hours) | Secondary: Hepatic Insulin Sensitivity, Glucose production (Ra) will be determined using stable isotopic tracer techniques. The extent to which Ra is suppressed at the end of 4 1/2 hours (when glucose Ra by liver has been submaximally suppressed) compared to basal (ΔRa) is directly proportional to hepatic insulin sensitivity., 4 1/2 hours into clamp study|Adipose Tissue Insulin Sensitivity, Insulin sensitivity at fat is directly proportional to insulin's ability to suppress lipolysis. Thus, we will determine the extent to which submaximal insulin stimulation (4 1/2 hours into the study) suppresses glycerol and non-esterified free fatty acids (NEFAs) compared to baseline. The extent to which these two metabolites are suppressed is directly proportional to insulin sensitivity in adipose tissue. Here the suppression of NEFA is taken as the secondary outcome parameter., 4 1/2 hours into clamp study
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| Sponsor/Collaborators: |
Sponsor: Vanderbilt University
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| Gender: |
ALL
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| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
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| Enrollment: |
33
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2016-12
|
| Completion Date: |
2019-02
|
| Results First Posted: |
2019-08-01
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| Last Update Posted: |
2019-08-01
|
| Locations: |
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02971202
|
