Incretin Regulation of Insulin Secretion in Monogenic Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01795144

Enrollment

Registered

2013-02-20

Start date

2014-01-31

Completion date

2017-03-31

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monogenic Diabetes

Brief summary

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

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

Interventions

DRUGGLP-1

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

DRUGExendin 9-39

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Yes

Inclusion criteria

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 +

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026