Type 2 DiabetesNCT02021695
DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Weill Medical College of Cornell University at 1 site in Qatar.
Trial summary
With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the investigators intend to measure the changes in DNA methylation and gene expression in blood monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are persistent or can be reversed by improving… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Injection or infusion
- How many people
- 249 participants
- Where
- 1 siteQatar
- Study dates
- Sep 2013to Dec 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited for the study at Hamad Medical Corporation. Most of the subjects will belong to the outpatients clinics. However, the subjects with bad Diabetes control might be recruited from the inpatient clinic as well.
Who may be able to join
- Must provide informed consent
- Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
- In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity)
- Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).
Who cannot join
- Diagnosis of Type-I Diabetes
- Active situational diabetes (steroids use/pregnancy)
- Active infection or acute illness of any kind
- Chronic inflammation (auto-immune diseases) or infection
- Evidence of malignancy within the past 5 years
- Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies (e.g. sickle cell disease and thalassemia), increases red-cell turnover (e.g. hemolytic anemia and spherocytosis.
- Evidence of malignancy within the past 5 years
- Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies
Trial locations and contacts
1 site in 1 country.
About this study
With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the investigators intend to measure the changes in DNA methylation and gene expression in blood monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are persistent or can be reversed by improving diabetes control.
Read the detailed description
The global prevalence of Type 2 Diabetes (T2D) is rapidly rising throughout most regions of the developed and developing world. In Middle East countries, particularly in the Gulf Council countries, the diabetes pandemic along with the rates of obesity have risen due to the adoption of a modern lifestyle. In the Qatari population alone, T2D is highly prevalent as 18% of the Qatari adults are estimated to suffer from this disease. Consanguineous marriages, sedentary lifestyle, obesity and bad dietary habits are cited as the main causes for this high incidence rate. Chronic hyperglycemia caused by long-term uncontrolled diabetes state can lead to devastating complications such as cardiovascular diseases, neuropathy, and retinopathy. Such complications are also highly prevalent in the Qatari population, perhaps due to the relatively low adherence to clinical guidelines but vary among Qatari individuals based on their genetic predisposition and shared family environment.It is already known that inflammation is part of the complex biochemical process of initiating and further developing cardiovascular complications of diabetes. Experimental models have showed that exposure to hyperglycemia induces epigenomic changes in inflammatory pathways, which subsequently regulate gene expression leading to the development of vascular inflammation. The investigators therefore hypothesized that chronic hyperglycemia leads to altered DNA methylation and dysregulation of gene expression in peripheral blood monocytes and lymphocytes in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- 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 |
|---|---|---|
| Group I: Non-diabetic controls | Group I: Non-diabetic controls Good overall health without history of Type II diabetes. Normal fasting glucose level (<100 mg/dL) and HbA1C < 5.7% Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). | |
| Group II: Diabetic with HbA1C<7% | Group II: HbA1C<7% Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). | |
| Group III: Good controlled diabetics with 7 % <HbA1C < 10% | Group III Good controlled diabetics with 7 % <HbA1C < 10% Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). | |
| Group IV: Poorly controlled diabetics with HbA1C > 10%. | Group IV: Poorly controlled diabetics with HbA1C > 10%. Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA methylation and gene expression in blood monocytes and lymphocytes
Changes in DNA methylation and gene expression in blood monocytes and lymphocytes will be compared in healthy, diabetic and pre-diabetic subjects.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Cornell Medical College in Qatar
- Responsible party
- Sponsor
- Investigators
- Charbel Abi Khalil, MD, Principal investigator, Weill Cornell Medical College in Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021695
- Sponsor's protocol ID
- 13-00023 [JIRB]
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2013
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02021695
- Acronym / sponsor ID
- 13-00023 [JIRB]
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Cornell Medical College in Qatar
- Study start
- Sep 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 27 Dec 2013 (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.
With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the investigators intend to measure the changes in DNA methylation and gene expression in blood monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are persistent or can be reversed by improving diabetes control.
Detailed description
The global prevalence of Type 2 Diabetes (T2D) is rapidly rising throughout most regions of the developed and developing world. In Middle East countries, particularly in the Gulf Council countries, the diabetes pandemic along with the rates of obesity have risen due to the adoption of a modern lifestyle. In the Qatari population alone, T2D is highly prevalent as 18% of the Qatari adults are estimated to suffer from this disease. Consanguineous marriages, sedentary lifestyle, obesity and bad dietary habits are cited as the main causes for this high incidence rate. Chronic hyperglycemia caused by long-term uncontrolled diabetes state can lead to devastating complications such as cardiovascular diseases, neuropathy, and retinopathy. Such complications are also highly prevalent in the Qatari population, perhaps due to the relatively low adherence to clinical guidelines but vary among Qatari individuals based on their genetic predisposition and shared family environment.It is already known that inflammation is part of the complex biochemical process of initiating and further developing cardiovascular complications of diabetes. Experimental models have showed that exposure to hyperglycemia induces epigenomic changes in inflammatory pathways, which subsequently regulate gene expression leading to the development of vascular inflammation. The investigators therefore hypothesized that chronic hyperglycemia leads to altered DNA methylation and dysregulation of gene expression in peripheral blood monocytes and lymphocytes in patients with type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Non-diabetic controls | – | –Group I: Non-diabetic controls Good overall health without history of Type II diabetes. Normal fasting glucose level (<100 mg/dL) and HbA1C < 5.7% Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). |
| Group II: Diabetic with HbA1C<7% | – | –Group II: HbA1C<7% Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). |
| Group III: Good controlled diabetics with 7 % <HbA1C < 10% | – | –Group III Good controlled diabetics with 7 % <HbA1C < 10% Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). |
| Group IV: Poorly controlled diabetics with HbA1C > 10%. | – | –Group IV: Poorly controlled diabetics with HbA1C > 10%. Also: 1. Must provide informed consent 2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus 3. In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity) 4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited for the study at Hamad Medical Corporation. Most of the subjects will belong to the outpatients clinics. However, the subjects with bad Diabetes control might be recruited from the inpatient clinic as well.
Key inclusion criteria (4 listed)
- Must provide informed consent
- Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
- In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity)
- Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).
Key exclusion criteria (8 listed)
- Diagnosis of Type-I Diabetes
- Active situational diabetes (steroids use/pregnancy)
- Active infection or acute illness of any kind
- Chronic inflammation (auto-immune diseases) or infection
- Evidence of malignancy within the past 5 years
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
DNA methylation and gene expression in blood monocytes and lymphocytes
Time frame: 1 hour
Changes in DNA methylation and gene expression in blood monocytes and lymphocytes will be compared in healthy, diabetic and pre-diabetic subjects.
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 27 Jan 2022.
- 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.
Charbel Abi Khalil, MD principal investigator
Weill Cornell Medical College in 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 Type 2 Diabetes, 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 4 inclusion and 8 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 27 Jan 2022. 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 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?
DNA methylation and gene expression in blood monocytes and lymphocytes (time frame: 1 hour). 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 Jan 2022.