Phase 1
N=33
Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)
Type 1 Diabetes Mellitus · Maturity-Onset Diabetes of the Young, Type 2 · MODY2 · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT02971202 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Whole-body Glucose Utilization (Rd) — 8.5; 11.0; 12.1 mg/kg FFM/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Hyperinsulinemic, euglycemic clamp (Drug); 20% dextrose (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole-body Glucose Utilization (Rd) |
8.5; 11.0; 12.1 | — |
| SECONDARY Hepatic Insulin Sensitivity |
1.9; 2.1; 1.7 | — |
| SECONDARY Adipose Tissue Insulin Sensitivity |
122.4; 382.3; 392.7 | — |
Summary
The purpose of this study is to determine the key factors influencing insulin sensitivity in type 1 diabetes (T1DM) and maturity onset diabetes of the young, type 2 (MODY2).
Our study tests the hypothesis that decreased insulin sensitivity is primarily driven by chronically elevated insulin levels in the blood rather than chronic elevations in blood sugar.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria for all subjects:
- BMI 19-28 kg/m^2
Additional inclusion criteria for T1DM subjects:
- Age 13-51
- T1DM duration 1-20 years
- HbA1c 5.9-8.0%
Additional inclusion criteria for MODY2 subjects:
- age 13-51
- positive GCK genetic sequencing
- HbA1c 5.9-8.0%
Additional inclusion criteria for control subjects:
- age 18-5.1
- HbA1c = 1 episode in the past 3 months or diagnosis of hypoglycemia unawareness)
- diabetes comorbidities (>= 1 trip to emergency department for poor glucose control in the past 6 months, New York Heart Association Class II-IV cardiac functional status, systolic blood pressure > 140 and diastolic blood pressure > 100 mmHg, fasting triglycerides > 400 mg/dL, liver transaminases > 2 times the upper limit of normal, renal transplantation or serum creatinine > 1.5 mg/dL)
- confounding medications (any systemic glucocorticoid, any antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any oral contraceptive pill with > 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, any anti-hypertensive, any-antilipidemic)
- pregnancy
- Tanner stage 0.7 ng/mL
Data sourced from ClinicalTrials.gov (NCT02971202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.