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Type 2 DiabetesNCT04081064

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

A study testing 10-week exercise programme based on aerobic interval and resistance training in people with Type 2 Diabetes, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
10-week exercise programme based on aerobic interval and resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteQatar
Study dates
15 Jan 2019to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Monica C Skarulis, MD contact

974 50013990

myoung@hamad.qa

Ibrahem Abdalhakam, MD contact

974 40254991

ibrahemabdalhakam1@gmail.com

Qatar1 site, 1 recruiting

  • Hamad Medical Corporation

    Doha, PO BOX 3050

    Monica C Skarulis, MD, 974 44392734, myoung@hamad.qa

    Ibrahem Adalhakam, MD, 974 44390969, ibrahemabdalhakam1@gmail.com

    Recruiting

Other trials in Qatar

About this study

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

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
Being tested
10-week exercise programme based on aerobic interval and resistance training
Keywords
Obese, Non-obese, Qatar
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10-week exercise programme based on aerobic interval and resistance trainingBehavioural

    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.

Study groups in NCT04081064
Study groupRoleWhat they receive
Non-obese Qatar residents with type 2 diabetesExperimentalNewly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >18.5 and <30.0 kg/m2
Receives: Behavioral: 10-week exercise programme based on aerobic interval and resistance training
Obese Qatar residents with type 2 diabetesExperimentalNewly diagnosed (e.g <5 years) Type 2 diabetics Qatar residents with a body mass index (BMI) of >30.0 to <40.0 kg/m2
Receives: Behavioral: 10-week exercise programme based on aerobic interval and resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin sensitivity

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

    Measured: 10 weeks

Secondary outcomes (14)

  1. Glucose regulation/ insulin sensitivity

    Glucose regulation and insulin sensitivity will be assessed via a 4-hour Oral glucose tolerance test procedure.

    Measured: 10 weeks

  2. Pancreatic beta-cell function

    Pancreatic beta-cell function will be assessed using a 3-hour Arginine stimulation test procedure.

    Measured: 10 weeks

  3. Hepatic insulin resistance index

    The measurement of hepatic insulin resistance index will completed during euglycemic clamp procedure.

    Measured: 10 weeks

  4. Vascular reactivity

    Endothelial reactivity will be assessed during the euglycemic clamp procedure, using an standard blood pressure arm cuff and the VENDYS instrument.

    Measured: 10 weeks

  5. 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

    Measured: 10 weeks

  6. 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.

    Measured: 10 weeks

  7. 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.

    Measured: 10 weeks

  8. 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.

    Measured: 10 weeks

  9. 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.

    Measured: 10 weeks

  10. Cardiorespiratory fitness (estimated maximal oxygen uptake)

    Maximal oxygen uptake (VO2max) will be estimated using the Astrand and Rhyming cycle ergometer protocol.

    Measured: 10 weeks

  11. Upper body strength

    Upper body strength will be determined via handgrip strength using a handgrip dynanmometer. Assessments will be conducted on both hands.

    Measured: 10 weeks

  12. Physical function

    Physical function will be measured using the 6-minute walk test.

    Measured: 10 weeks

  13. Lower body strength

    Lower body strength will be assessed using the 30-s sit to stand test.

    Measured: 10 weeks

  14. Fasting Plasma glucose

    The number of particiapnts that have improvement in fasting plasma glucose.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start15 Jan 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04081064
Sponsor's protocol ID
MRC-03-17-0025
Status last verified
Jun 2019
First submitted
24 Jul 2019
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 10-week exercise programme based on aerobic interval and resistance training in people with Type 2 Diabetes, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Monica C Skarulis, MD (974 50013990, myoung@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin sensitivity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04081064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.

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