Sri Lanka Diabetes Aerobic and Resistance Training Study

Not Applicable

Conditions: Type 2 diabetes mellitus

Registration Number: SLCTR/2016/017

Lead Sponsor: niversity Grants Commission

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up complete

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Males and females aged 35-60 years.
2. Sri Lankan origin.
3. Diagnosed with type 2 diabetes mellitus within the last 6 years.

Exclusion Criteria

1. Blood Glycosylated hemoglobin (HbA1c) levels <7.0 % or >11.5%.
2. History of significant cardiovascular (ischemic heart disease etc.), respiratory (asthma, chronic obstructive pulmonary disease etc) or musculoskeletal diseases (osteoarthritis of major joints etc).
3. On insulin or thiazolidinedione therapy/other than standard oral hypoglycemic agents (metformin / sulfonylureas.).
4. Any advanced diabetes induced end-stage organ damage (vascular, retinopathy, nephropathy, neuropathy, retinal hemorrhage or detachment, history of laser therapy).
5. People with a cognitive impairment, an intellectual disability, or a mental illness.
6. Current participation in supervised Resistance Training or Aerobic Training.
7. Engaged in Resistance Training in previous 6 months.
8. Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Absolute change in HbA1c <br>2. Absolute change in total body fat percentage values [measured using Dual energy x ray absorptiometry (DEXA) full body scan].<br><br><br> [At baseline, and at the end of 12 weeks (following 24 exercise sessions). ]<br>

Secondary Outcome Measures

Name	Time	Method
1. Plasma lipid profile<br>2. Liver profile<br>3. Muscle strength:Percentage (%) change in One Repetition Maximum (1RM).<br>4. Lean mass: Dual energy x ray absorptiometry (DEXA) full body scan.<br>5. Blood pressure<br>6. Cardiovascular endurance: McArdle Step test and YMCA cycle ergometer test.<br>7. Quality of life: SF-36 quality-of-life outcomes questionnaire<br>8. Change in food preference measured by the Leeds Food Preference Questionnaire (LFPQ) [Outcomes 1-7 will be assessed at baseline and at the end of the 12 weeks of intervention.<br><br>Outcome 8 will be assessed pre-and post-exercise session at baseline and at the final session (end of 12 weeks).<br><br>]<br>