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Incretin Regulation of Insulin Secretion in Monogenic Diabetes

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01795144
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
37.9
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Incretin Regulation of Insulin Secretion in Monogenic Diabetes
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incretin Effect [Baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT01795144
    Other Study ID Numbers:
    • 12-1517
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    Apr 10, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Glucagon
    Glucagon-Like Peptide 1

    Study Results

    No Results Posted as of Apr 10, 2017