Incretin Regulation of Insulin Secretion in Monogenic Dia... | NCT01795144

Studies
Incretin Regulation of Insulin Secretion in Monogenic Diabetes

NCT01795144

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Apr 10, 2017Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Monogenic Diabetes

Interventions

GLP-1
Exendin 9-39

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Feb 15, 2013

First Submission Date that Met QC Criteria

Feb 19, 2013

First Posted Date

Feb 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2017

Last Update Posted Date

Apr 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy controls	Active Comparator	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 Drug: Exendin 9-39
Monogenic diabetes	Experimental	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 Drug: Exendin 9-39

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLP-1	Drug	OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion	Healthy controls Monogenic diabetes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 +

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Siri Atma W Greeley, MD, PhD	University of Chicago	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

We do not plan to share data with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D052216	Glucagon-Like Peptide 1
C083773	exendin (9-39)

Ancestor Terms

ID	Term
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones

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Browse Branches

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