NCT04081064

Impact of Body Composition and Exercise on Clinical, Metabolic and Molecular Parameters in Type 2 Diabetics in Qatar

Exploring the Impact of Body Fat Profile, and a Physical Exercise Intervention on Clinical, Metabolic and Molecular Parameters in Qatar Residents With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 T2DM. The primary aim of this study is to understand the impact of the ratio of lean body mass (metabolically active skeletal muscle) to adipose tissue mass on the severity of insulin resistance and pancreatic beta cell dysfunction in non-obese and obese Qatar residents with T2DM. An exercise programme aimed to increase lean mass and aerobic capacity will be initiated for a period 10 weeks in non-obese and obese early onset diabetics who are residents of Qatar. The effect of the exercise programme on total body fat, regional fat distribution and intramuscular and intrahepatic fat content using magnetic resonance imaging (MRI) in these groups of diabetics will be assessed and related to total body insulin sensitivity and β-cell function as measured with the gold standard methods: the euglycemic clamp technique and arginine stimulation. Genetic approaches including candidate gene testing and non-targeted miRNA expression profiling and metabolomics are employed. Physical fitness pre- and post-intervention will also be assessed. The impact of the exercise programme on conventional inflammatory markers, the phenotype of immune cells, metabolic hormones, and markers of oxidative stress, endoplasmic reticulum stress and heat shock response (Hsp-72, Hsp -40/DNAJB3 and Hsp-25) are studied in relation to metabolic changes. Through this study, the contributions of fitness, fatness and exercise training on insulin resistance and beta cell function will be elucidated in Qatari residents with T2DM.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	10-week exercise programme based on aerobic interval and resistance training	The intervention will take place over 10 weeks. Participants will complete three sessions per week; each sessions will be scheduled at least 24 hours apart. Two sessions per week will consist of aerobic interval exercise and resistance training, and one session per week will consist of aerobic interval exercise only.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-12-31
• Completion: 2022-07-31
• First posted: 2019-09-06
• Last updated: 2019-10-07

Locations

1 site across 1 country: Qatar