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Clinical Trials/NCT02660476
NCT02660476TerminatedNot Applicable

Qatar Universal Diabetes Outcomes (QUDOS) Study

Weill Cornell Medical College in Qatar1 site in 1 country475 target enrollmentStarted: October 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
475
Locations
1
Primary Endpoint
Diabetes Complications (Nephropathy, Neuropathy, Retinopathy)

Study Overview

Brief 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.

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Known pregnancy or planning pregnancy during the duration of study;
  • Congenital disorders;
  • Terminal illness;
  • Enrolled in a clinical trial involving medication;
  • Uncontrolled mental illness preventing participation;
  • Those who have already experienced a definitive microvascular complication:
  • i. End-stage renal disease; ii. Major amputation; iii. Blindness.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Sleep and sleep related breathing disorders(Baseline (Cross-Sectional))
  • Mental Health(Baseline (Cross-Sectional))
  • Physical activity(Baseline (Cross-Sectional))

Investigators

Sponsor
Weill Cornell Medical College in Qatar
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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