Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Benzocaine; Glucagon; Hormones; Insulin; Insulin, Globin Zinc; Somatostatin

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 < 5.5%

Exclusion Criteria:

Exclusion criteria for all subjects:

• severe hypoglycemia (>= 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 < 5

Additional exclusion criteria for T1DM subjects

• any diabetes medication except insulin

• fasting c-peptide > 0.7 ng/mL