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

Completed · Phase 1

Conditions studied: Type 1 Diabetes Mellitus, Maturity-Onset Diabetes of the Young, Type 2, MODY2, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT02971202

Run by

Vanderbilt University

People needed

33

Starts

2016-12-01

Expected to finish

2019-02-01

Last updated by the study team

2019-08-01

Who can join

Age: 13 and older, up to 51. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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