Phase 1
Completed 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
Source: ClinicalTrials.gov NCT02971202 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Whole-body Glucose Utilization (Rd) — 8.5; 11.0; 12.1 mg/kg FFM/min
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.
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 | — |
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. Informational only — not medical advice.