DiabetesRHIENCT00811044
Regulation of Hepatic Insulin Extraction
An observational study of Diabetes, run by Washington University School of Medicine.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers \& otherwise healthy diabetic volunteers (do not require insulin for glucose control).
Who may be able to join
- 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
Who cannot join
- < 18 or > 65 years of age
- medications that affect glucose (sugar) levels
- kidney disease
- liver disease
- heart/cardiovascular disease
About this study
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
- 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
Read the 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.
- Conditions
- Diabetes
- Keywords
- diabetes, genetics, oral glucose tolerance testing, family history of diabetes, gestational diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Genes affecting the development of Type 2 diabetes will be identified
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startOct 2000
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: PI, Dr. K. Polonsky has moved to the University of Chicago.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Kenneth S Polonsky, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811044
- Sponsor's protocol ID
- 00-0589
- Other IDs
- 5R01DK031842-26
- Acronym
- RHIE
- Status last verified
- Jun 2018
- First submitted
- 17 Dec 2008
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00811044
- Acronym / sponsor ID
- RHIE / 00-0589
- Conditions
- Diabetes
- Keywords
- diabetes, genetics, oral glucose tolerance testing, family history of diabetes, gestational diabetes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI, Dr. K. Polonsky has moved to the University of Chicago.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Chicago, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2000
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers \& otherwise healthy diabetic volunteers (do not require insulin for glucose control).
Key inclusion criteria (6 listed)
- ages 18-65
- non-diabetic
- diabetes controlled with diet or with pills
- no family history of diabetes
- family history of type 2 diabetes
Key exclusion criteria (5 listed)
- < 18 or > 65 years of age
- medications that affect glucose (sugar) levels
- kidney disease
- liver disease
- heart/cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genes affecting the development of Type 2 diabetes will be identified
Time frame: 1 year
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth S Polonsky, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genes affecting the development of Type 2 diabetes will be identified (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.