Incretin Regulation of Insulin Secretion in Monogenic Diabetes

NCT01795144 | Completed Phase 1

• 1 other identifier: 12-1517
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Monogenic Diabetes

Outcome Measures

Primary Outcomes (1)

• Incretin Effect

  Directly calculated from the difference between oral and IV stimulated insulin secretion

  Baseline

Study Arms (2)

Healthy controls

ACTIVE COMPARATOR

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

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

Monogenic diabetes

EXPERIMENTAL

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

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

Interventions

GLP-1 DRUG

OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion

Also known as: Glucagon-like peptide-1 (GLP-1)

Healthy controls; Monogenic diabetes

Exendin 9-39 DRUG

OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion

Also known as: Glucagon-Like Peptide 1 (GLP-1) receptor antagonist

Healthy controls; Monogenic diabetes

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Glucagon-Like Peptide 1; exendin (9-39)

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Siri Atma W Greeley, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 20, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)