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

NCT04081064 | Unknown

• 1 other identifier: MRC-03-17-0025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Keywords

Obese; Non-obese; Qatar

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Insulin sensitivity will be assessed using a modification of the De Fronzo technique 2-hour Euglycemic Clamp procedure.

  10 weeks

Secondary Outcomes (14)

• Glucose regulation/ insulin sensitivity

  10 weeks

• Pancreatic beta-cell function

  10 weeks

• Hepatic insulin resistance index

  10 weeks

• Vascular reactivity

  10 weeks

• Body Mass Index (BMI)

  10 weeks

Other Outcomes (1)

• Heart rate during exercise sessions

  10 weeks

Study Arms (2)

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

Behavioral: 10-week exercise programme based on aerobic interval and resistance training

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

Behavioral: 10-week exercise programme based on aerobic interval and resistance training

Interventions

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.

Non-obese Qatar residents with type 2 diabetes; Obese Qatar residents with type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Hamad Bin Khalifa University: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, PO BOX 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Monica C Skarulis, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica C Skarulis, MD

CONTACT

974 50013990; myoung@hamad.qa

Ibrahem Abdalhakam, MD

CONTACT

974 40254991; ibrahemabdalhakam1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 6, 2019
• Study Start: January 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2022
• Last Updated: October 7, 2019

Record last verified: 2019-06

Locations

QA (1)