Qatar Universal Diabetes Outcomes (QUDOS) Study (QUDOS)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus; Type 2 Diabetes Mellitus

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 Type: Observational
• Enrollment (Actual): 475

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Weill Cornell Medicine Qatar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

1. Type 1 and Type 2 diabetes mellitus;
2. Male or Female;
3. Resident in Qatar;
4. MENA birthplace and family origin;
5. 18-70 years old;
6. Capable to give informed consent and complete the study.

Exclusion Criteria:

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:

i. End-stage renal disease; ii. Major amputation; iii. Blindness.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (Cross-Sectional)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health	To assess the relationships between T2DM and depression through questionnaires	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	Baseline (Cross-Sectional)
Physical activity	To assess the relationships between T2DM and physical activity using an Actiwatch	Baseline (Cross-Sectional)

Collaborators and Investigators

• Sponsor: Weill Cornell Medical College in Qatar
• Collaborators: Hamad Medical Corporation
• Investigators: Principal Investigator: Shahrad Taheri, PhD, Weill Cornell Medical College in Qatar

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: January 17, 2016
• First Posted (Estimated): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Obesity; Stress; Diet; Health; Complication; Middle East and North Africa country; Obstructive Sleep Apnoea (OSA)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: JIRB: 14-0032. MRC: #14461/14