Diabetes MellitusQUDOSNCT02660476
Qatar Universal Diabetes Outcomes (QUDOS) Study
An observational study of Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
Trial summary
QUDOS is a cross-sectional population study aiming to answer key questions about diabetes and its complications in Qatar as well as identify factors associated with the development and progression of diabetes complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes Mellitus
- How many people
- 475 participants
- Where
- 1 siteQatar
- Study dates
- Oct 2014to 1 Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients 18-70 years old with diabetes, who are a resident in Qatar or born in one of the MENA countries with family originating from MENA countries, will be recruited from one of the following sites: * Primary health care centers * Hamad General Hospital * Al-Wakra Hospital * Al-Khor Hospital
Who may be able to join
- Type 1 and Type 2 diabetes mellitus;
- Male or Female;
- Resident in Qatar;
- MENA birthplace and family origin;
- 18-70 years old;
- Capable to give informed consent and complete the study.
Who cannot join
- 1. Known pregnancy or planning pregnancy during the duration of study; 2. Congenital disorders; 3. Terminal illness; 4. Enrolled in a clinical trial involving medication; 5. Uncontrolled mental illness preventing participation; 6. Those who have already experienced a definitive microvascular complication:
- End-stage renal disease; ii. Major amputation; iii. Blindness.
Trial locations and contacts
1 site in 1 country.
About this study
QUDOS is a cross-sectional population study aiming to answer key questions about diabetes and its complications in Qatar as well as identify factors associated with the development and progression of diabetes complications.
Read the detailed description
QUDOS aims to gain a better understanding of diabetes in primary and secondary care over a period of 24 months.
A range of patients with diabetes will be sampled (including those with Type 1 diabetes as this group is under-studied in Qatar). This will be important in designing appropriate intervention plans that will improve diabetic patients' health conditions to prevent or delay the onset of complications and will provide a strong foundation for longitudinal study.
The broad objectives of the study are:
QUDOS 1: Aims to recruit 1,700 diabetic patients (including 200 with type 1 diabetes mellitus (independent of healthcare setting)) attending the hospitals and primary care and to collect the following data:
- Demographics: age, sex, ethnicity, socio-economic background, smoking status;
- Anthropometrics: vital signs, height, weight, body fat percentage, fat mass, neck and waist circumference;
- Medical History: medications, complications, comorbidities, latest HbA1c and lipid profiles and family medical history;
- Routine laboratory data;
- Lifestyle: diet, physical activity,;
- Sleep: quality and daytime sleepiness;
- Cognition and Mental Health: depression, anxiety, stress and memory;
- Diabetes microvascular complications: diabetic neuropathy, urine albumin/creatinine ratio; routine retinal screening data.
- Gut microbiome from a stool sample
QUDOS 2: To further characterise 500 patients, from the total 1500 patients with T2DM recruited in QUDOS 1, who accept to continue with QUDOS 2 (a more detailed study and assessment).
This phase aims to concentrate on the following aspects:
- Obstructive sleep apnoea;
- Sleep duration and quality;
- Diet;
- Objective physical activity;
- Stress;
- Quality of Life;
- Depression and anxiety;
- Perceived control of health;
- Detailed neuropathy screening;
- Cardiovascular function;
- Cognitive function;
- Biological samples.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diet, Middle East and North Africa country, Health, Complication, Cardiovascular disease, Obesity, Stress, Obstructive Sleep Apnoea (OSA)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity, Sleep Apnea, Obstructive
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 |
|---|---|---|
| QUDOS 1 | Aims to recruit 1,700 diabetic patients (including 200 with type 1 diabetes mellitus (independent of healthcare setting)) attending the hospitals and primary care | |
| QUDOS 2 | To further characterise 500 patients, from the total 1500 patients with T2DM recruited in QUDOS 1, who accept to continue with QUDOS 2 (a more detailed study and assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Complications (Nephropathy, Neuropathy, Retinopathy)
Our primary analyses will be conducted to explore the potential cross-sectional relationships amongst proposed factors related to type 2 diabetes complications
Measured: Baseline (Cross-Sectional)
Secondary outcomes (3)
Mental Health
To assess the relationships between T2DM and depression through questionnaires
Measured: Baseline (Cross-Sectional)
Sleep and sleep related breathing disorders
To assess the relationships between T2DM and sleep disordered breathing, sleep duration and sleep quality through a home sleep study
Measured: Baseline (Cross-Sectional)
Physical activity
To assess the relationships between T2DM and physical activity using an Actiwatch
Measured: Baseline (Cross-Sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startOct 2014
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: The study has been closed by our IRB due to the PI's departure from the Institution.
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.
- 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
- Cross-sectional
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Cornell Medical College in Qatar
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Shahrad Taheri, PhD, Principal investigator, Weill Cornell Medical College in Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660476
- Sponsor's protocol ID
- JIRB: 14-0032. MRC: #14461/14
- Acronym
- QUDOS
- Status last verified
- Jun 2023
- First submitted
- 20 May 2015
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qatar Universal Diabetes Outcomes (QUDOS) Study
- ClinicalTrials.gov ID
- NCT02660476
- Acronym / sponsor ID
- QUDOS / JIRB: 14-0032. MRC: #14461/14
- Conditions
- Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Diet, Middle East and North Africa country, Health, Complication, Cardiovascular disease, Obesity, Stress, Obstructive Sleep Apnoea (OSA)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study has been closed by our IRB due to the PI's departure from the Institution.
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Weill Cornell Medical College in QatarUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation
- Study start
- Oct 2014
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Jan 2016 (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.
QUDOS is a cross-sectional population study aiming to answer key questions about diabetes and its complications in Qatar as well as identify factors associated with the development and progression of diabetes complications.
Detailed description
QUDOS aims to gain a better understanding of diabetes in primary and secondary care over a period of 24 months.
A range of patients with diabetes will be sampled (including those with Type 1 diabetes as this group is under-studied in Qatar). This will be important in designing appropriate intervention plans that will improve diabetic patients' health conditions to prevent or delay the onset of complications and will provide a strong foundation for longitudinal study.
The broad objectives of the study are:
QUDOS 1: Aims to recruit 1,700 diabetic patients (including 200 with type 1 diabetes mellitus (independent of healthcare setting)) attending the hospitals and primary care and to collect the following data:
- Demographics: age, sex, ethnicity, socio-economic background, smoking status;
- Anthropometrics: vital signs, height, weight, body fat percentage, fat mass, neck and waist circumference;
- Medical History: medications, complications, comorbidities, latest HbA1c and lipid profiles and family medical history;
- Routine laboratory data;
- Lifestyle: diet, physical activity,;
- Sleep: quality and daytime sleepiness;
- Cognition and Mental Health: depression, anxiety, stress and memory;
- Diabetes microvascular complications: diabetic neuropathy, urine albumin/creatinine ratio; routine retinal screening data.
- Gut microbiome from a stool sample
QUDOS 2: To further characterise 500 patients, from the total 1500 patients with T2DM recruited in QUDOS 1, who accept to continue with QUDOS 2 (a more detailed study and assessment).
This phase aims to concentrate on the following aspects:
- Obstructive sleep apnoea;
- Sleep duration and quality;
- Diet;
- Objective physical activity;
- Stress;
- Quality of Life;
- Depression and anxiety;
- Perceived control of health;
- Detailed neuropathy screening;
- Cardiovascular function;
- Cognitive function;
- Biological samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QUDOS 1 | – | –Aims to recruit 1,700 diabetic patients (including 200 with type 1 diabetes mellitus (independent of healthcare setting)) attending the hospitals and primary care |
| QUDOS 2 | – | –To further characterise 500 patients, from the total 1500 patients with T2DM recruited in QUDOS 1, who accept to continue with QUDOS 2 (a more detailed study and assessment). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 18-70 years old with diabetes, who are a resident in Qatar or born in one of the MENA countries with family originating from MENA countries, will be recruited from one of the following sites: * Primary health care centers * Hamad General Hospital * Al-Wakra Hospital * Al-Khor Hospital
Key inclusion criteria (6 listed)
- Type 1 and Type 2 diabetes mellitus;
- Male or Female;
- Resident in Qatar;
- MENA birthplace and family origin;
- 18-70 years old;
Key exclusion criteria (2 listed)
- 1. Known pregnancy or planning pregnancy during the duration of study; 2. Congenital disorders; 3. Terminal illness; 4. Enrolled in a clinical trial involving medication; 5. Uncontrolled mental illness preventing participation; 6. Those who have already experienced a definitive microvascular complication:
- End-stage renal disease; ii. Major amputation; iii. Blindness.
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
Diabetes Complications (Nephropathy, Neuropathy, Retinopathy)
Time frame: Baseline (Cross-Sectional)
Our primary analyses will be conducted to explore the potential cross-sectional relationships amongst proposed factors related to type 2 diabetes complications
3 secondary outcomes
Mental Health
Time frame: Baseline (Cross-Sectional)
Sleep and sleep related breathing disorders
Time frame: Baseline (Cross-Sectional)
Physical activity
Time frame: Baseline (Cross-Sectional)
Results and safety
The study was stopped early (reason given: The study has been closed by our IRB due to the PI's departure from the Institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
Shahrad Taheri, PhD 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 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Weill Cornell Medical College in Qatar 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 2 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 22 Jun 2023. 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: The study has been closed by our IRB due to the PI's departure from the Institution.). 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.
What does the primary outcome measure?
Diabetes Complications (Nephropathy, Neuropathy, Retinopathy) (time frame: Baseline (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 22 Jun 2023.