Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hamad Bin Khalifa University | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-obese Qatar residents with type 2 diabetes | Experimental | Newly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >18.5 and <30.0 kg/m2 |
|
| Obese Qatar residents with type 2 diabetes | Experimental | Newly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >30.0 to <40.0 kg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10-week exercise programme based on aerobic interval and resistance training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Insulin sensitivity will be assessed using a modification of the De Fronzo technique 2-hour Euglycemic Clamp procedure. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose regulation/ insulin sensitivity | Glucose regulation and insulin sensitivity will be assessed via a 4-hour Oral glucose tolerance test procedure. | 10 weeks |
| Pancreatic beta-cell function |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate during exercise sessions | Heart rate will be recorded using polar H10 monitors and the polar team system throughout exercise programme. | 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica C Skarulis, MD | Contact | 974 50013990 | myoung@hamad.qa | |
| Ibrahem Abdalhakam, MD | Contact | 974 40254991 | ibrahemabdalhakam1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Monica C Skarulis, MD | Hamad Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Recruiting | Doha | PO BOX 3050 | Qatar |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Pancreatic beta-cell function will be assessed using a 3-hour Arginine stimulation test procedure.
| 10 weeks |
| Hepatic insulin resistance index | The measurement of hepatic insulin resistance index will completed during euglycemic clamp procedure. | 10 weeks |
| Vascular reactivity | Endothelial reactivity will be assessed during the euglycemic clamp procedure, using an standard blood pressure arm cuff and the VENDYS instrument. | 10 weeks |
| Body Mass Index (BMI) | Patient's weight and height will be measured in kilograms (kg) and meters (m), respectively, and combined to report BMI in kg/m^2 | 10 weeks |
| Body fat profiling | Mesenteric, hepatic, subcutaneous and skeletal muscle infiltrating fat will be measured with a 3.0T MR-scanner using a whole-body Dixon protocol. Hepatic fat content and skeletal muscle fat infiltration will be measured. All measurements will be performed with 3T Phillips Ingenia scanner. | 10 weeks |
| Total body fat | Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive total body fat. | 10 weeks |
| Non-fat mass | Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive non-fat mass. | 10 weeks |
| Visceral adipose volume | Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive estimates of visceral adipose volume. | 10 weeks |
| Cardiorespiratory fitness (estimated maximal oxygen uptake) | Maximal oxygen uptake (VO2max) will be estimated using the Astrand and Rhyming cycle ergometer protocol. | 10 weeks |
| Upper body strength | Upper body strength will be determined via handgrip strength using a handgrip dynanmometer. Assessments will be conducted on both hands. | 10 weeks |
| Physical function | Physical function will be measured using the 6-minute walk test. | 10 weeks |
| Lower body strength | Lower body strength will be assessed using the 30-s sit to stand test. | 10 weeks |
| Fasting Plasma glucose | The number of particiapnts that have improvement in fasting plasma glucose. | 10 weeks |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |