Study Stopped
COVID-19
Mechanisms of Insulin Resistance and Exercise in South Asians
Effects of Exercise Training on Insulin Sensitivity in South Asians at Risk of Diabetes: the Roles of Skeletal Muscle Microvasculature and Mitochondrial Metabolism
1 other identifier
interventional
66
1 country
1
Brief Summary
This study determines the effect of aerobic and resistance exercise training on whole-body and skeletal muscle insulin sensitivity in south Asians and evaluate the mechanisms which contribute to improvements in insulin sensitivity after exercise training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedOctober 8, 2020
October 1, 2020
1.6 years
June 28, 2019
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whole-body Insulin sensitivity
Change in whole-body insulin sensitivity measured by hyperinsulinaemic-euglycaemic clamp.
Change between baseline and 12 weeks.
Secondary Outcomes (16)
Insulin-stimulated GLUT4 translocation
Change between baseline and 12 weeks.
Microvascular blood volume
Change between baseline and 12 weeks.
Muscle mitochondrial function
Change between baseline and 12 weeks.
Lipid droplet content in skeletal muscle
Change between baseline and 12 weeks.
Lipid droplet proximity to mitochondria in skeletal muscle
Change between baseline and 12 weeks.
- +11 more secondary outcomes
Study Arms (3)
Control Group
NO INTERVENTIONParticipants assigned to the control arm of the study will be asked to maintain their normal dietary and exercise habits.
Aerobic exercise group
EXPERIMENTALParticipants randomised to the aerobic exercise intervention will undertake a 12-week aerobic exercise training programme.
Resistance exercise group
EXPERIMENTALParticipants randomised to the resistance exercise intervention will undertake a 12-week aerobic exercise training programme.
Interventions
Participants will start with 3 x 20 minute exercise sessions in the first week, building up to 5 x 60 minutes of exercise by weeks 9-12 of the intervention, at an intensity of 65-80% of predicted maximum heart rate.
Participants will undertake two supervised sessions per week. The exercises performed during each session will consist of leg press, calf press, leg extension, leg curl, chest press, shoulder press, lateral pull down and seated row. Exercises will be performed at 60-80% 1RM. In weeks 1-2 participants will perform, during each session, a single set of 5-10 repetitions of each exercise (tiring but comfortably achievable) to ensure they are comfortable with the exercises and are performing these in the correct form. In weeks 3-4 participants will perform, during each session, two sets of each exercise to voluntary muscular failure - defined as not being able to perform single another repetition. In weeks 5-12 this will progress to 3 sets of each exercise to voluntary muscular failure, in each session.
Eligibility Criteria
You may qualify if:
- Male
- South Asian ethnicity (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin)
- Age 30-65 years
- At least 10% 10-year risk of developing type 2 diabetes, determined using the QDiabetes®2018 risk score (http://qdiabetes.org/2018/index.php)
You may not qualify if:
- Female
- Diabetes (physician diagnosed or HbA1c ≥48 mmol/mol on screening)
- History of cardiovascular disease
- Hypertension (taking anti-hypertensives or BP consistently ≥ 150/90 mmHg on screening).
- Regular participation in vigorous physical activity
- Regular participation in resistance exercise
- Current smoking
- Taking drugs or supplements thought to affect carbohydrate or lipid metabolism
- Taking drugs affecting blood clotting (e.g. aspirin)
- Current treatment with anti-obesity drugs
- Any other significant illness that would prevent full participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- Medical Research Councilcollaborator
Study Sites (1)
University of Glasgow
Glasgow, G12 8QQ, United Kingdom
Related Publications (1)
Marx N, Davies MJ, Grant PJ, Mathieu C, Petrie JR, Cosentino F, Buse JB. Guideline recommendations and the positioning of newer drugs in type 2 diabetes care. Lancet Diabetes Endocrinol. 2021 Jan;9(1):46-52. doi: 10.1016/S2213-8587(20)30343-0. Epub 2020 Nov 4.
PMID: 33159841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Gill, PhD
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Masking is not possible due to nature of intervention (exercise training programme).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 5, 2019
Study Start
August 1, 2021
Primary Completion
March 1, 2023
Study Completion
January 1, 2025
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share