Status:
UNKNOWN
Impact of Body Composition and Exercise on Clinical, Metabolic and Molecular Parameters in Type 2 Diabetics in Qatar
Lead Sponsor:
Hamad Medical Corporation
Collaborating Sponsors:
Hamad Bin Khalifa University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The prevalence of type 2 diabetes (T2DM) is increasing sharply around the world and obesity and sedentary lifestyles are driving the epidemic. Obesity is often, but not always present in patients with...
Eligibility Criteria
Inclusion
- New onset T2DM (\<5 years duration).
- Aged 18 and 60 years.
- Residents of Qatar with intention to stay for the duration of the study (approx 4 months)
- Otherwise healthy or with stable, treated medical conditions (hypertension, hyperlipidemia, hypothyroidism, etc.)
- Hemoglobin A1c (HbA1c) level \< 8%.
- "Diet and lifestyle" or metformin or DPP4 inhibitors prescribed for T2DM.
- Willingness and ability to comply with the exercise protocol and study duration.
Exclusion
- Type 1 Diabetes Mellitus or history of hospitalization for hyperglycemia or suspected ketoacidosis.
- T2DM prescribed insulin, or any other anti-diabetic agent other than metformin or DDP4 inhibitors.
- HbA1c ≥8.0%.
- Body mass index (BMI) ≤ 18.5 kg/m2 (underweight) and ≥ 40 kg/m2 (morbid obese).
- Reported weight loss or gain (± 2 kg) over the preceding three months;
- Pregnant or lactating women or women planning to be pregnant during the course of the study.
- History of regular exercise (the equivalent of 150 minutes of moderate intensity aerobic and/or 2 sessions of resistance training per week) or of a job that demands a similar degree of physical activity within the past 6 months.
- Use of medications that affect glucose metabolism, glucose tolerance or body weight including oral corticosteroids and atypical anti-psychotics.
- History of cardiovascular disease including previous myocardial infarction, congestive cardiac failure, valvular heart disease, stroke or the use of medication to alter coagulation including daily aspirin, anti-platelet drugs or any class of anticoagulant or a clinically significant abnormality on electrocardiogram that in the opinion of a consulting cardiologist should prevent participation.
- History of chronic diseases associated with inflammation and/or the daily use of anti-inflammatory or immunosuppressant medications for arthritis, gout, rheumatologic disorders, inflammatory bowel disease, or viral infections including hepatitis B, C and HIV.
- History of psychiatric disorders including current clinical depression, schizophrenia, bipolar disorder or subjects with known claustrophobia.
- History of chronic neurological disorders such as epilepsy, dementia or movement disorders.
- Hematocrit \<33%.
- Participation in other research studies that require blood drawing or any medical, nutritional or behavioral intervention.
- The presence of large ferromagnetic tattoos that may interfere with the MRI determination of body fat.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04081064
Start Date
January 15 2019
End Date
July 31 2022
Last Update
October 7 2019
Active Locations (1)
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1
Hamad Medical Corporation
Doha, Qatar, PO BOX 3050