Incretin Regulation of Insulin Secretion in Monogenic Diabetes

Monogenic Diabetes Clinical Trial

Official title:

Incretin Regulation of Insulin Secretion in Monogenic Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795144
• Other study ID #: 12-1517
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2013
• Last updated: April 6, 2017
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Monogenic Diabetes

Intervention

Drug:
• GLP-1
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
• Exendin 9-39
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incretin Effect	Directly calculated from the difference between oral and IV stimulated insulin secretion	Baseline