Regulation of Hepatic Insulin Extraction (RHIE)

Regulation of Hepatic Insulin Extraction:Alterations of Insulin Secretion in Subjects With Genetic Variants That Determine Risk for Non-Insulin Dependant Diabetes Mellitus

• 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

Study Overview

• Status: Withdrawn
• Conditions: Diabetes

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Chicago

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; genetics; gestational diabetes; oral glucose tolerance testing; family history of diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 00-0589; 5R01DK031842-26 (U.S. NIH Grant/Contract)