Regulation of Hepatic Insulin Extraction | NCT00811044

Studies
Regulation of Hepatic Insulin Extraction

NCT00811044

Sponsor

Washington University School of Medicine

Status

Withdrawn

Last Update Posted

Jun 27, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
5R01DK031842-26	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI, Dr. K. Polonsky has moved to the University of Chicago.

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Dec 17, 2008

First Submission Date that Met QC Criteria

Dec 17, 2008

First Posted Date

Dec 18, 2008Estimated

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

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

Name	Class
University of Chicago	OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

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

This study is in the area of Type 2 diabetes and genetics
Healthy Volunteers and those with mild type 2 diabetes may be eligible to participate
This study is searching for genes that may affect the body's processing/digestion of glucose/sugar

Detailed Description

This study is looking at the genetic influences of type 2 diabetes. It also is investigating the various gastric hormones including but not limited to: insulin, C-peptide, GIP, GLP, & Xenin.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Entry		This group is just entering the study and will need to be genotyped.
Affected		This group has been genotyped and has the gene undergoing study at that time.
Control		This group has been genotyped and does not have the gene currently under study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genes affecting the development of Type 2 diabetes will be identified		1 year

Secondary Outcomes

Measure	Description	Time Frame
Any differences between genetic groups in the metabolism of glucose/sugar will be studied to the extent that the data allow		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ages 18-65
non-diabetic
diabetes controlled with diet or with pills
no family history of diabetes
family history of type 2 diabetes
personal history of gestational diabetes

Exclusion Criteria:

< 18 or > 65 years of age
medications that affect glucose (sugar) levels
kidney disease
liver disease
heart/cardiovascular disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Volunteers & otherwise healthy diabetic volunteers (do not require insulin for glucose control).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth S Polonsky, MD	Washington University School of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided