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Regulation of Hepatic Insulin Extraction (RHIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00811044
Recruitment Status : Withdrawn (PI, Dr. K. Polonsky has moved to the University of Chicago.)
First Posted : December 18, 2008
Last Update Posted : October 4, 2010
Information provided by:

Study Description
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

Condition or disease

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 Design

Study Type : Observational
Estimated Enrollment : 1250 participants
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
Study Start Date : October 2000
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Groups and Cohorts

This group is just entering the study and will need to be genotyped.
This group has been genotyped and has the gene undergoing study at that time.
This group has been genotyped and does not have the gene currently under study.

Outcome Measures

Primary Outcome Measures :
  1. Genes affecting the development of Type 2 diabetes will be identified [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers & otherwise healthy diabetic volunteers (do not require insulin for glucose control).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811044

Sponsors and Collaborators
Washington University School of Medicine
University of Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kenneth S Polonsky, MD Washington University School of Medicine
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010

Keywords provided by Washington University School of Medicine:
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
Hypoglycemic Agents
Physiological Effects of Drugs