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This study has been withdrawn prior to enrollment.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:
Washington University School of Medicine
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
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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 |
|---|
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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.
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Affected
This group has been genotyped and has the gene undergoing study at that time.
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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 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 May 23, 2013