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

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ClinicalTrials.gov Identifier: NCT04081064
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Hamad Bin Khalifa University
Information provided by (Responsible Party):
Hamad Medical Corporation

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: 10-week exercise programme based on aerobic interval and resistance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-obese Qatar residents with type 2 diabetes
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
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.

Experimental: Obese Qatar residents with type 2 diabetes
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
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.




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 10 weeks ]
    Insulin sensitivity will be assessed using a modification of the De Fronzo technique 2-hour Euglycemic Clamp procedure.


Secondary Outcome Measures :
  1. Glucose regulation/ insulin sensitivity [ Time Frame: 10 weeks ]
    Glucose regulation and insulin sensitivity will be assessed via a 4-hour Oral glucose tolerance test procedure.

  2. Pancreatic beta-cell function [ Time Frame: 10 weeks ]
    Pancreatic beta-cell function will be assessed using a 3-hour Arginine stimulation test procedure.

  3. Hepatic insulin resistance index [ Time Frame: 10 weeks ]
    The measurement of hepatic insulin resistance index will completed during euglycemic clamp procedure.

  4. Vascular reactivity [ Time Frame: 10 weeks ]
    Endothelial reactivity will be assessed during the euglycemic clamp procedure, using an standard blood pressure arm cuff and the VENDYS instrument.

  5. Body Mass Index (BMI) [ Time Frame: 10 weeks ]
    Patient's weight and height will be measured in kilograms (kg) and meters (m), respectively, and combined to report BMI in kg/m^2

  6. Body fat profiling [ Time Frame: 10 weeks ]
    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.

  7. Total body fat [ Time Frame: 10 weeks ]
    Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive total body fat.

  8. Non-fat mass [ Time Frame: 10 weeks ]
    Dual energy X-ray absorptiometry (DEXA), via the Lunar iDXA instrument and enCORE software will be used to derive non-fat mass.

  9. Visceral adipose volume [ Time Frame: 10 weeks ]
    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. Cardiorespiratory fitness (estimated maximal oxygen uptake) [ Time Frame: 10 weeks ]
    Maximal oxygen uptake (VO2max) will be estimated using the Astrand and Rhyming cycle ergometer protocol.

  11. Upper body strength [ Time Frame: 10 weeks ]
    Upper body strength will be determined via handgrip strength using a handgrip dynanmometer. Assessments will be conducted on both hands.

  12. Physical function [ Time Frame: 10 weeks ]
    Physical function will be measured using the 6-minute walk test.

  13. Lower body strength [ Time Frame: 10 weeks ]
    Lower body strength will be assessed using the 30-s sit to stand test.

  14. Glycated Hemoglobin (HbA1c) [ Time Frame: 10 weeks ]
    A fasting blood sample will be obtained for analysis.

  15. Plasma glucose [ Time Frame: 10 weeks ]
    A fasting blood sample will be obtained for analysis


Other Outcome Measures:
  1. Heart rate during exercise sessions [ Time Frame: 10 weeks ]
    Heart rate will be recorded using polar H10 monitors and the polar team system throughout exercise programme.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. New onset T2DM (<5 years duration).
  2. Aged 18 and 60 years.
  3. Residents of Qatar with intention to stay for the duration of the study (approx 4 months)
  4. Otherwise healthy or with stable, treated medical conditions (hypertension, hyperlipidemia, hypothyroidism, etc.)
  5. Hemoglobin A1c (HbA1c) level < 8%.
  6. "Diet and lifestyle" or metformin or DPP4 inhibitors prescribed for T2DM.
  7. Willingness and ability to comply with the exercise protocol and study duration.

Exclusion Criteria:

  1. Type 1 Diabetes Mellitus or history of hospitalization for hyperglycemia or suspected ketoacidosis.
  2. T2DM prescribed insulin, or any other anti-diabetic agent other than metformin or DDP4 inhibitors.
  3. HbA1c ≥8.0%.
  4. Body mass index (BMI) ≤ 18.5 kg/m2 (underweight) and ≥ 40 kg/m2 (morbid obese).
  5. Reported weight loss or gain (± 2 kg) over the preceding three months;
  6. Pregnant or lactating women or women planning to be pregnant during the course of the study.
  7. 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.
  8. Use of medications that affect glucose metabolism, glucose tolerance or body weight including oral corticosteroids and atypical anti-psychotics.
  9. 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.
  10. 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.
  11. History of psychiatric disorders including current clinical depression, schizophrenia, bipolar disorder or subjects with known claustrophobia.
  12. History of chronic neurological disorders such as epilepsy, dementia or movement disorders.
  13. Hematocrit <33%.
  14. Participation in other research studies that require blood drawing or any medical, nutritional or behavioral intervention.
  15. The presence of large ferromagnetic tattoos that may interfere with the MRI determination of body fat.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081064


Contacts
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Contact: Monica C Skarulis, MD 974 50013990 myoung@hamad.qa
Contact: Ibrahem Abdalhakam, MD 974 40254991 ibrahemabdalhakam1@gmail.com

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, PO BOX 3050
Contact: Monica C Skarulis, MD    974 44392734    myoung@hamad.qa   
Contact: Ibrahem Adalhakam, MD    974 44390969    ibrahemabdalhakam1@gmail.com   
Sponsors and Collaborators
Hamad Medical Corporation
Hamad Bin Khalifa University
Investigators
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Principal Investigator: Monica C Skarulis, MD Hamad Medical Corporation

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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04081064     History of Changes
Other Study ID Numbers: MRC-03-17-0025
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamad Medical Corporation:
Obese
Non-obese
Qatar
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases