NCT00811044

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2000

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

14.7 years

First QC Date

December 17, 2008

Last Update Submit

June 25, 2018

Conditions

Keywords

diabetesgeneticsoral glucose tolerance testingfamily history of diabetesgestational diabetes

Outcome Measures

Primary Outcomes (1)

  • Genes affecting the development of Type 2 diabetes will be identified

    1 year

Secondary Outcomes (1)

  • Any differences between genetic groups in the metabolism of glucose/sugar will be studied to the extent that the data allow

    1 year

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

Diabetes MellitusDiabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kenneth S Polonsky, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

October 1, 2000

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 27, 2018

Record last verified: 2018-06