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Completed

NCT Number: NCT01795144

Incretin Regulation of Insulin Secretion in Monogenic Diabetes

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

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Key information

Conditions

Monogenic Diabetes

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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:

  • Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points
  • 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
  • OGTT during GLP-1 infusion
  • IGI during Exendin-9 infusion

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1

Drug

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

Other names: Glucagon-like peptide-1 (GLP-1)

Exendin 9-39

Drug

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

Other names: Glucagon-Like Peptide 1 (GLP-1) receptor antagonist

Primary outcomes

  1. Incretin Effect

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2013
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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