Incretin Regulation of Insulin Secretion in Monogenic Diabetes

Phase 1

Completed

• Conditions: Monogenic Diabetes
• Interventions: Drug: GLP-1; Drug: Exendin 9-39

• Registration Number: NCT01795144
• Lead Sponsor: University of Chicago

Brief Summary

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

Detailed 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:

1. Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points

2. 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

3. OGTT during GLP-1 infusion

4. IGI during Exendin-9 infusion

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Study Start: 2014-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 +

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy controls	GLP-1	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
Healthy controls	Exendin 9-39	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
Monogenic diabetes	GLP-1	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
Monogenic diabetes	Exendin 9-39	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

Primary Outcome Measures

Name	Time	Method
Incretin Effect	Baseline	Directly calculated from the difference between oral and IV stimulated insulin secretion

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States