Diabetes MellitusNCT01172743
Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar)
An observational study of Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Weill Medical College of Cornell University at 1 site in Qatar.
Trial summary
This protocol is designed to gather a small amount of blood for extraction of DNA for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes, and controls without diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes Mellitus
- How many people
- 450 participants
- Where
- 1 siteQatar
- Study dates
- Jun 2009to Jul 2020
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetes group will be taken from (1)individuals visiting the Medicine Department at the Hamad Medical Corporation(HMC), Qatar for standard clinical care, (2)outpatient adult individuals seen at the HMCdiabetes clinics, (3)individuals who have participated in the following IRB protocol #s:0608008703, #0602008388 and HMC protocol #231, (4)ndividuals who attend clinics at the Qatar Diabetes Association (QDA), and (5)Individuals who work at the governmental ministries of Qatar. Controls will be obtained from volunteers without a history of diabetes. Family members of patients may be asked to participate in the study.
Who may be able to join
- Must provide informed consent
- Males and females, age 18 years and older
- Documented evidence of diabetes using at least one of the following: (1) blood tests consistent with Type-II diabetes; (2) oral glucose tolerance tests consistent with Type-II diabetes; (3) subject taking medication to treat Type-II diabetes.
- Must provide informed consent
- Males or females ages 18 years and older
- Resolved gestational diabetes
Who cannot join
- Individual refuses consent
- Pregnant females with gestational diabetes
- Type-I diabetes
- Normal control group
- Individual refuses consent.
- Individuals with history of diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol is designed to gather a small amount of blood for extraction of DNA for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes, and controls without diabetes. Investigators aim to understand the genetics of diabetes, and will use the cells and serum from this blood to perform genotyping and gene expression studies of individuals with diabetes and relevant controls.
Read the detailed description
This protocol is designed to collect a small amount of blood for extraction of DNA (genetic material) for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes and controls without diabetes. Additionally, this protocol will recruit individuals from the following locations: the Qatar Diabetes Association, the governmental ministries of Qatar, and subjects who have participated in Dr. Bener's HMC protocol #231 entitled "A preliminary study of genetic pre-disposition to diabetic mellitus in the state of Qatar." Individuals with diabetes may also be recruited from the Hamad Hospital outpatient adult diabetes clinics (there are eight diabetes clinics each week) and/or from the population of subjects who previously participated in Dr. Mushlin's IRB approved protocol #0608008703 entitled "Comparing the Clinical Management and Genetic Markers of Diabetes in Qatar to International Standards" at Hamad Medical Corporation or IRB approved protocol #0602008388 entitled "The Impact of Cardiac and Genetic Risk Factors on Acute Myocardial Infarction and Cerebrovascular Stroke in Qatar: A Case-Control Study". In this protocol, researchers will survey medical records of patients with diabetes, in order to study the clinical characteristics of these individuals, and the researchers will collect blood to evaluate the genetic characteristics of individuals with diabetes. The researchers will also collect blood samples of individuals without diabetes to serve as control.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Diabetes, Type-2, Adult Onset
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Diabetes | Individuals with diabetes that fit eligibility criteria. | |
| Normal Control | Individuals without history of diabetes. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2020
- Study completionJul 2020
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar, Hamad Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Study director, Weill Cornell Medical College, NY and Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172743
- Sponsor's protocol ID
- 0904010340
- Other IDs
- HMC Protocol # 9093/09
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2010
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar)
- ClinicalTrials.gov ID
- NCT01172743
- Acronym / sponsor ID
- 0904010340
- Conditions
- Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Diabetes, Type-2, Adult Onset
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar, Hamad Medical Corporation
- Study start
- Jun 2009
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 30 Jul 2010 (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 protocol is designed to gather a small amount of blood for extraction of DNA for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes, and controls without diabetes. Investigators aim to understand the genetics of diabetes, and will use the cells and serum from this blood to perform genotyping and gene expression studies of individuals with diabetes and relevant controls.
Detailed description
This protocol is designed to collect a small amount of blood for extraction of DNA (genetic material) for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes and controls without diabetes. Additionally, this protocol will recruit individuals from the following locations: the Qatar Diabetes Association, the governmental ministries of Qatar, and subjects who have participated in Dr. Bener's HMC protocol #231 entitled "A preliminary study of genetic pre-disposition to diabetic mellitus in the state of Qatar." Individuals with diabetes may also be recruited from the Hamad Hospital outpatient adult diabetes clinics (there are eight diabetes clinics each week) and/or from the population of subjects who previously participated in Dr. Mushlin's IRB approved protocol #0608008703 entitled "Comparing the Clinical Management and Genetic Markers of Diabetes in Qatar to International Standards" at Hamad Medical Corporation or IRB approved protocol #0602008388 entitled "The Impact of Cardiac and Genetic Risk Factors on Acute Myocardial Infarction and Cerebrovascular Stroke in Qatar: A Case-Control Study". In this protocol, researchers will survey medical records of patients with diabetes, in order to study the clinical characteristics of these individuals, and the researchers will collect blood to evaluate the genetic characteristics of individuals with diabetes. The researchers will also collect blood samples of individuals without diabetes to serve as control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | –Individuals with diabetes that fit eligibility criteria. |
| Normal Control | – | –Individuals without history of diabetes. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes group will be taken from (1)individuals visiting the Medicine Department at the Hamad Medical Corporation(HMC), Qatar for standard clinical care, (2)outpatient adult individuals seen at the HMCdiabetes clinics, (3)individuals who have participated in the following IRB protocol #s:0608008703, #0602008388 and HMC protocol #231, (4)ndividuals who attend clinics at the Qatar Diabetes Association (QDA), and (5)Individuals who work at the governmental ministries of Qatar. Controls will be obtained from volunteers without a history of diabetes. Family members of patients may be asked to participate in the study.
Key inclusion criteria (6 listed)
- Must provide informed consent
- Males and females, age 18 years and older
- Documented evidence of diabetes using at least one of the following: (1) blood tests consistent with Type-II diabetes; (2) oral glucose tolerance tests consistent with Type-II diabetes; (3) subject taking medication to treat Type-II diabetes.
- Must provide informed consent
- Males or females ages 18 years and older
Key exclusion criteria (6 listed)
- Individual refuses consent
- Pregnant females with gestational diabetes
- Type-I diabetes
- Normal control group
- Individual refuses consent.
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ronald G Crystal, MD study director
Weill Cornell Medical College, NY and Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Weill Medical College of Cornell University at 1 site in Qatar.
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 6 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: stopped early, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Lack of funding.). Results are not available in the source record.
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.
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 31 Jul 2020.