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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Monica C Skarulis, MD
  • Phone Number: 974 50013990
  • Email: myoung@hamad.qa

Study Contact Backup

Study Locations

  • Qatar
      • Doha, Qatar, PO BOX 3050

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamad Medical Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamad Bin Khalifa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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