Incretin Regulation of Insulin Secretion in Monogenic Diabetes

April 6, 2017 updated by: University of Chicago
The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy controls

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
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
Other Names:
  • Glucagon-like peptide-1 (GLP-1)
Drug: Exendin 9-39
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
Other Names:
  • Glucagon-Like Peptide 1 (GLP-1) receptor antagonist
Experimental: Monogenic diabetes

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
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
Other Names:
  • Glucagon-like peptide-1 (GLP-1)
Drug: Exendin 9-39
OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
Other Names:
  • Glucagon-Like Peptide 1 (GLP-1) receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incretin Effect
Time Frame: Baseline
Directly calculated from the difference between oral and IV stimulated insulin secretion
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Siri Atma W Greeley, MD, PhD, University Of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not plan to share data with other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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