DiabetesNCT00837408
Genetics of Type 2 Diabetes Among Han Chinese
An observational study of Diabetes and Hypertension, run by National Human Genome Research Institute (NHGRI) at 1 site in China.
Trial summary
Objectives: To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among Han Chinese. To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetes, Hypertension
- How many people
- 2,379 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2009to 3 Feb 2012
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases will be drawn from Type 2 Diabetics attending clinics at the Suizhou Central Hospital. Controls will be ethnicity-matched individuals from the community served by this hospital.
Who may be able to join
- Cases Men and women with confirmed type 2 diabetes mellitus that are either on treatment for diabetes or newly diagnose with blood sugar reading on more than one occasion exceeding or equal to 126 mg/dl. These persons must be above the age of 25 years. In this regard, all newly diagnosed participants will be required to visit the clinic on the following day to perform fasting blood glucose test to confirm previous results.
- Controls Men and women with fasting plasma glucose (FPG) less than 100 mg/dl (5.6 mmol/l). Controls must be above age 25 years and should be ethnically matched to the cases. Enrolled cases and controls have to be unrelated. Therefore, only one person may be enrolled from each family unless they are husband and wife.
- Attempts will be made to enroll an equal number of men and women. To ensure that ethnic distribution is maintained in the parent study, we are proposing to enroll only Han Chinese participants.
Who cannot join
- People who do not meet the above criteria (e.g., younger than 24, without the blood sugar requirements, etc). No more than one non-spouse member of each family. No prisoners, pregnant women or fetuses will be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives:
- To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among Han Chinese.
- To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort.
- To conduct replication studies of the top-100 scoring variants in three independent African and European ancestry samples.
- To investigate whether diabetes-associated variants discovered in European populations increase diabetes risk in Han Chinese.
Read more
Eligibility:
- Patients 25 years of age with newly diagnosed T2D in Suizhou, China. Control subjects are nondiabetics, age and ethnically matched to patients.
Design:
- The study design for both patients and controls consists of the following steps:
- Discuss informed consent process and obtain signed informed consent form. Informed consent will be administered by trained clinic staff.
- Assign study ID (barcode)
- Administer questionnaires
- Obtain spot urine sample
- Measure blood pressure
- Obtain anthropometric measurements including body composition
- Perform finger prick for blood glucose level
- Obtain venous blood samples
- Perform eye examination
- On the following day, perform confirmatory blood glucose for the small subset of participants requiring confirmation of previous test result
- DNA extraction of stored samples will be done at either the National Institutes of Health or the laboratory in China.
- GWAS will be conducted using publicly available software packages.
Read the detailed description
This research protocol is designed to study the genetic basis of Type 2 Diabetes (T2D) in Han Chinese. This project taking place at Suizhou Central Hospital complements several years of similar research activities conducted by Dr. Rotimi s lab in populations of the African Diaspora with study sites in Nigeria, Ghana, Kenya and the US. Suizhou Hospital was selected because of the existence of an excellent team of research investigators, infrastructure and more importantly, the availability of a large population from which to enroll and examine persons with diabetes and normal controls. Previous funding from Dr. Rotimi s lab at Howard University made it possible for Dr. Jiang and staff to enroll 1000 cases and controls. Therefore, the goal of the current project is to enroll additional 1500 cases of T2D and 1500 ethnically matched Han controls from Suizhou to facilitate the conduct of genome-wide association study (GWAS) and candidate gene/loci studies in Han, Chinese. The current project will increase the number of subjects for future GWAS, linkage disequilibrium (LD) mapping and functional studies to over 4,000 ethnically balanced cases (greater than 2,000) and controls (greater than 2,000). Identified candidate genes/loci will be investigated by re-sequencing and functional studies will be conducted to identify susceptibility variants for diabetes and associated complications including obesity, hypertension, nephropathy, neuropathy and retinopathy. Given past activities, it is also anticipated that this resource will form the basis of multiple collaborations between Dr. Rotimi s lab, several NIH intramural researchers and non-NIH scientists.
- Conditions
- Diabetes, Hypertension
- Keywords
- GWAS
- Medical subject headings
- Diabetes Mellitus, Hypertension
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 |
|---|---|---|
| Cases | Individuals with Type 2 Diabetes | |
| Controls | Individuals without Type 2 Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 Diabetes
Diagnosis of type 2 diabetes based on blood glucose measurement.
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study start3 Feb 2009
- Primary completion3 Feb 2012
- Study completion3 Feb 2012
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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles N Rotimi, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837408
- Sponsor's protocol ID
- 999909071
- Other IDs
- 09-HG-N071
- Status last verified
- Sep 2020
- First submitted
- 4 Feb 2009
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Type 2 Diabetes Among Han Chinese
- ClinicalTrials.gov ID
- NCT00837408
- Acronym / sponsor ID
- 999909071
- Conditions
- Diabetes, Hypertension
- Keywords
- GWAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,379 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 3 Feb 2009 (actual)
- Primary completion
- 3 Feb 2012 (actual)
- Study completion
- 3 Feb 2012 (actual)
- First posted
- 5 Feb 2009 (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.
Objectives:
- To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among Han Chinese.
- To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort.
- To conduct replication studies of the top-100 scoring variants in three independent African and European ancestry samples.
- To investigate whether diabetes-associated variants discovered in European populations increase diabetes risk in Han Chinese.
Eligibility:
- Patients 25 years of age with newly diagnosed T2D in Suizhou, China. Control subjects are nondiabetics, age and ethnically matched to patients.
Design:
- The study design for both patients and controls consists of the following steps:
- Discuss informed consent process and obtain signed informed consent form. Informed consent will be administered by trained clinic staff.
- Assign study ID (barcode)
- Administer questionnaires
- Obtain spot urine sample
- Measure blood pressure
- Obtain anthropometric measurements including body composition
- Perform finger prick for blood glucose level
- Obtain venous blood samples
- Perform eye examination
- On the following day, perform confirmatory blood glucose for the small subset of participants requiring confirmation of previous test result
- DNA extraction of stored samples will be done at either the National Institutes of Health or the laboratory in China.
- GWAS will be conducted using publicly available software packages.
Detailed description
This research protocol is designed to study the genetic basis of Type 2 Diabetes (T2D) in Han Chinese. This project taking place at Suizhou Central Hospital complements several years of similar research activities conducted by Dr. Rotimi s lab in populations of the African Diaspora with study sites in Nigeria, Ghana, Kenya and the US. Suizhou Hospital was selected because of the existence of an excellent team of research investigators, infrastructure and more importantly, the availability of a large population from which to enroll and examine persons with diabetes and normal controls. Previous funding from Dr. Rotimi s lab at Howard University made it possible for Dr. Jiang and staff to enroll 1000 cases and controls. Therefore, the goal of the current project is to enroll additional 1500 cases of T2D and 1500 ethnically matched Han controls from Suizhou to facilitate the conduct of genome-wide association study (GWAS) and candidate gene/loci studies in Han, Chinese. The current project will increase the number of subjects for future GWAS, linkage disequilibrium (LD) mapping and functional studies to over 4,000 ethnically balanced cases (greater than 2,000) and controls (greater than 2,000). Identified candidate genes/loci will be investigated by re-sequencing and functional studies will be conducted to identify susceptibility variants for diabetes and associated complications including obesity, hypertension, nephropathy, neuropathy and retinopathy. Given past activities, it is also anticipated that this resource will form the basis of multiple collaborations between Dr. Rotimi s lab, several NIH intramural researchers and non-NIH scientists.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Individuals with Type 2 Diabetes |
| Controls | – | –Individuals without Type 2 Diabetes |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be drawn from Type 2 Diabetics attending clinics at the Suizhou Central Hospital. Controls will be ethnicity-matched individuals from the community served by this hospital.
Key inclusion criteria (3 listed)
- Cases Men and women with confirmed type 2 diabetes mellitus that are either on treatment for diabetes or newly diagnose with blood sugar reading on more than one occasion exceeding or equal to 126 mg/dl. These persons must be above the age of 25 years. In this regard, all newly diagnosed participants will be required to visit the clinic on the following day to perform fasting blood glucose test to confirm previous results.
- Controls Men and women with fasting plasma glucose (FPG) less than 100 mg/dl (5.6 mmol/l). Controls must be above age 25 years and should be ethnically matched to the cases. Enrolled cases and controls have to be unrelated. Therefore, only one person may be enrolled from each family unless they are husband and wife.
- Attempts will be made to enroll an equal number of men and women. To ensure that ethnic distribution is maintained in the parent study, we are proposing to enroll only Han Chinese participants.
Key exclusion criteria (1 listed)
- People who do not meet the above criteria (e.g., younger than 24, without the blood sugar requirements, etc). No more than one non-spouse member of each family. No prisoners, pregnant women or fetuses will be included in this study.
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
Type 2 Diabetes
Time frame: Cross-sectional
Diagnosis of type 2 diabetes based on blood glucose measurement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Charles N Rotimi, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
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 and Hypertension, run by National Human Genome Research Institute (NHGRI) at 1 site in China.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Sep 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Type 2 Diabetes (time frame: Cross-sectional). 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 25 Sep 2020.