Incretin Regulation of Insulin Secretion in Monogenic Diabetes

NCT ID: NCT01795144

Last Updated: 2017-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Monogenic Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

GLP-1

Intervention Type DRUG

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

Exendin 9-39

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

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

Exendin 9-39

Intervention Type DRUG

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

Interventions

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GLP-1

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

Intervention Type DRUG

Exendin 9-39

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

Intervention Type DRUG

Other Intervention Names

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Glucagon-like peptide-1 (GLP-1) Glucagon-Like Peptide 1 (GLP-1) receptor antagonist

Eligibility Criteria

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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 +


* 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

Healthy Controls:


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siri Atma W Greeley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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12-1517

Identifier Type: -

Identifier Source: org_study_id

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