Incretin Regulation of Insulin Secretion in Monogenic Diabetes

The University of Chicago

Status and phase: Completed; Phase 1

Conditions: Monogenic Diabetes

Treatments: Drug: GLP-1; Drug: Exendin 9-39

Study type: Interventional

Funder types: Other

Identifiers

NCT01795144

12-1517

Details and patient eligibility

About

The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.

Full description

Monogenic diabetes patients and healthy matched controls will be admitted to the University of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on separate days:

Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points OGTT during GLP-1 infusion IGI during Exendin-9 infusion

Enrollment: 10 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Monogenic Diabetes Subjects:

Inclusion Criteria:

• Diagnosis of monogenic diabetes
• Previously participated in US Neonatal Diabetes Registry (IRB 15617B) or Genetics of diabetes mellitus (IRB 6858)
• Age: 18 years +

Exclusion Criteria:

• Pregnancy
• Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension

Healthy Controls:

Inclusion Criteria:

• Good general health
• Stable weight for 6 months
• Age: 18 years +

Exclusion Criteria:

• Pregnancy
• Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Healthy controls

Active Comparator group

Description:

Healthy controls will be matched (age, gender, BMI) to monogenic diabetes subjects. Healthy controls will participate in the following: OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion

Treatment:

Drug: Exendin 9-39

Drug: GLP-1

Monogenic diabetes

Experimental group

Description:

Monogenic diabetes subjects will be matched (age, gender, BMI) to healthy controls. Monogenic diabetes subjects will participate in the following: OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion

Treatment:

Drug: Exendin 9-39

Drug: GLP-1