Regulation of Hepatic Insulin Extraction (RHIE)

This study has been withdrawn prior to enrollment.
(PI, Dr. K. Polonsky has moved to the University of Chicago.)
Sponsor:
Collaborators:
University of Chicago
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00811044
First received: December 17, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose
  • 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

Condition
Diabetes

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Regulation of Hepatic Insulin Extraction:Alterations of Insulin Secretion in Subjects With Genetic Variants That Determine Risk for Non-Insulin Dependant Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Genes affecting the development of Type 2 diabetes will be identified [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any differences between genetic groups in the metabolism of glucose/sugar will be studied to the extent that the data allow [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples are collected for Glucose & various human peptide measurements and DNA. As peptide assay evolves, specimens may be re-tested.


Estimated Enrollment: 1250
Study Start Date: October 2000
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811044

Sponsors and Collaborators
Washington University School of Medicine
University of Chicago
Investigators
Principal Investigator: Kenneth S Polonsky, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Dr. Kenneth Polonsky, MD, Washington University in St. Louis
ClinicalTrials.gov Identifier: NCT00811044     History of Changes
Other Study ID Numbers: 00-0589, 5R01DK031842-26
Study First Received: December 17, 2008
Last Updated: October 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
diabetes
genetics
oral glucose tolerance testing
family history of diabetes
gestational diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014