- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081064
Impact of Body Composition and Exercise on Clinical, Metabolic and Molecular Parameters in Type 2 Diabetics in Qatar
October 3, 2019 updated by: Hamad Medical Corporation
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monica C Skarulis, MD
- Phone Number: 974 50013990
- Email: myoung@hamad.qa
Study Contact Backup
- Name: Ibrahem Abdalhakam, MD
- Phone Number: 974 40254991
- Email: ibrahemabdalhakam1@gmail.com
Study Locations
-
-
-
Doha, Qatar, PO BOX 3050
- Recruiting
- Hamad medical corporation
-
Contact:
- Monica C Skarulis, MD
- Phone Number: 974 44392734
- Email: myoung@hamad.qa
-
Contact:
- Ibrahem Adalhakam, MD
- Phone Number: 974 44390969
- Email: ibrahemabdalhakam1@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin sensitivity
Time Frame: 10 weeks
|
Insulin sensitivity will be assessed using a modification of the De Fronzo technique 2-hour Euglycemic Clamp procedure.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Pancreatic beta-cell function
Time Frame: 10 weeks
|
Pancreatic beta-cell function will be assessed using a 3-hour Arginine stimulation test procedure.
|
10 weeks
|
Hepatic insulin resistance index
Time Frame: 10 weeks
|
The measurement of hepatic insulin resistance index will completed during euglycemic clamp procedure.
|
10 weeks
|
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.
|
10 weeks
|
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
|
10 weeks
|
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.
|
10 weeks
|
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.
|
10 weeks
|
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.
|
10 weeks
|
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 weeks
|
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.
|
10 weeks
|
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.
|
10 weeks
|
Physical function
Time Frame: 10 weeks
|
Physical function will be measured using the 6-minute walk test.
|
10 weeks
|
Lower body strength
Time Frame: 10 weeks
|
Lower body strength will be assessed using the 30-s sit to stand test.
|
10 weeks
|
Fasting Plasma glucose
Time Frame: 10 weeks
|
The number of particiapnts that have improvement in fasting plasma glucose.
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Monica C Skarulis, MD, Hamad medical corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2019
Primary Completion (ANTICIPATED)
December 31, 2020
Study Completion (ANTICIPATED)
July 31, 2022
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (ACTUAL)
September 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRC-03-17-0025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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