Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and M… (NCT02971202) | Clinical Trial Compass
CompletedPhase 1
Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)
United States33 participantsStarted 2016-12
Plain-language 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.
Who can participate
Age range13 Years – 51 Years
SexALL
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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
What they're measuring
1
Whole-body Glucose Utilization (Rd)
Timeframe: End of clamp study (the study will last 8 hours)