Insulin ResistanceNCT04007926
Mechanisms of Insulin Resistance and Exercise in South Asians
A study testing Aerobic exercise programme and Resistance exercise programme in people with Insulin Resistance, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Aerobic exercise programme and Resistance exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2021to Jan 2025
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Training on Insulin Sensitivity in South Asians at Risk of Diabetes: the Roles of Skeletal Muscle Microvasculature and Mitochondrial Metabolism
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.
Read the detailed description
South Asians (SA) have 2-4 fold higher risk of type 2 diabetes and develop the disease at lower body weights and younger ages than white Europeans. Lower cardiorespiratory fitness and capacity for muscle fat oxidation contributes substantially to SAs' greater insulin resistance, the extent to which this can be improved by exercise training is unclear. This randomised controlled trial will investigate the effects of a 12-week aerobic or resistance exercise training intervention on insulin sensitivity (hyperinsulinaemic-euglycaemic clamp) in South Asian adults (22 control, 22 aerobic exercise group and 22 resistance exercise group). The study will also explore the mechanisms within skeletal muscle which mediate these changes by evaluating aerobic and resistance exercise-training induced changes: in basal and insulin-stimulated microvascular blood volume (using contrast-enhanced ultrasound); skeletal muscle mitochondrial function; and lipid droplet morphology and spatial interaction with mitochrondria, muscle fibre capillarisation, endothelial content of key enzymes controlling dilation/constriction and GLUT-4 translocation (using confocal immunofluorescence microscopy and transmission electron microscopy methods). Thus, this work will integrate physiological and molecular data to determine the extent to which exercise training can improve insulin sensitivity in SA and the mechanisms underpinning this improvement. This knowledge is important for optimising diabetes prevention interventions in SAs and identification of potential novel therapeutic targets.
- Conditions
- Insulin Resistance
- Being tested
- Aerobic exercise programme, Resistance exercise programme
- Keywords
- insulin resistance, aerobic exercise, resistance exercise, exercise training, South Asians
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise programmeBehavioural
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.
Resistance exercise programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants assigned to the control arm of the study will be asked to maintain their normal dietary and exercise habits. |
| Aerobic exercise group | Experimental | Participants randomised to the aerobic exercise intervention will undertake a 12-week aerobic exercise training programme. Receives: Behavioral: Aerobic exercise programme |
| Resistance exercise group | Experimental | Participants randomised to the resistance exercise intervention will undertake a 12-week aerobic exercise training programme. Receives: Behavioral: Resistance exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body Insulin sensitivity
Change in whole-body insulin sensitivity measured by hyperinsulinaemic-euglycaemic clamp.
Measured: Change between baseline and 12 weeks.
Secondary outcomes (16)
Insulin-stimulated GLUT4 translocation
Change in insulin-stimulated GLUT4 translocation in muscle biopsies from vastus lateralis using immunofluorescence microscopy
Measured: Change between baseline and 12 weeks.
Microvascular blood volume
Change in fold-increase in insulin stimulated quadriceps muscle blood volume measured using contrast enhanced ultrasound.
Measured: Change between baseline and 12 weeks.
Muscle mitochondrial function
Change in mitochondrial function (oxygen consumption rate) in isolated skeletal muscle mitochondria from the vastus lateralis measured using respirometry
Measured: Change between baseline and 12 weeks.
Lipid droplet content in skeletal muscle
Change in fibre type-specific (type 1 and type 2) and subcellular-specific (subsarcolemmal and intermyofibrillar) lipid droplet content in muscle biopsies from vastus lateralis using immunofluorescence microscopy
Measured: Change between baseline and 12 weeks.
Lipid droplet proximity to mitochondria in skeletal muscle
Change in proportion of lipid droplets in contact with mitochondria in subsarcolemmal and intermyofibrillar compartments of type 1 and type 2 muscle fibres in muscle biopsies from vastus lateralis using immunofluorescence microscopy
Measured: Change between baseline and 12 weeks.
Microvascular density in skeletal muscle
Change in fibre-type specific capillarisation in muscle biopsies from vastus lateralis
Measured: Change between baseline and 12 weeks.
Change in enzymes controlling insulin-mediated increases in perfusion in skeletal muscle
Change in endothelial specific protein content and phosphorylation of key microvascular enzymes in muscle biopsies from vastus lateralis assessed using quantitative immunofluorescence.
Measured: Change between baseline and 12 weeks.
Maximal oxygen uptake
Change in maximal oxygen uptake consumption assessed using continuous incremental uphill walking protocol until volitional exhaustion.
Measured: Change between baseline and 12 weeks.
Muscle maximal voluntary contraction
Change in knee extensor muscles maximal voluntary contraction
Measured: Change between baseline and 12 weeks.
Lower body muscle strength
Change in 1-RM (one maximal repetition) (kg) for leg press.
Measured: Change between baseline and 12 weeks.
Upper body muscle strength
Change in 1-RM (one maximal repetition) (kg) for chest press.
Measured: Change between baseline and 12 weeks.
Grip strength
Change in grip strength (kg).
Measured: Change between baseline and 12 weeks.
Fat mass
Change in fat mass measured with bioelectrical impedance analysis (BIA).
Measured: Change between baseline and 12 weeks.
Fat-free mass
Change in fat-free mass measured with bioelectrical impedance analysis (BIA).
Measured: Change between baseline and 12 weeks.
Weight
Change in weight (kg).
Measured: Change between baseline and 12 weeks.
Waist circumference
Change in waist circumference (cm)
Measured: Change between baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startAug 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Professor Jason Gill, University of Glasgow
- Investigators
- Jason Gill, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007926
- Sponsor's protocol ID
- 265320
- Status last verified
- Oct 2020
- First submitted
- 28 Jun 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33159841
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Insulin Sensitivity in South Asians at Risk of Diabetes: the Roles of Skeletal Muscle Microvasculature and Mitochondrial Metabolism
- ClinicalTrials.gov ID
- NCT04007926
- Acronym / sponsor ID
- 265320
- Conditions
- Insulin Resistance
- Keywords
- insulin resistance, aerobic exercise, resistance exercise, exercise training, South Asians
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Aug 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
South Asians (SA) have 2-4 fold higher risk of type 2 diabetes and develop the disease at lower body weights and younger ages than white Europeans. Lower cardiorespiratory fitness and capacity for muscle fat oxidation contributes substantially to SAs' greater insulin resistance, the extent to which this can be improved by exercise training is unclear. This randomised controlled trial will investigate the effects of a 12-week aerobic or resistance exercise training intervention on insulin sensitivity (hyperinsulinaemic-euglycaemic clamp) in South Asian adults (22 control, 22 aerobic exercise group and 22 resistance exercise group). The study will also explore the mechanisms within skeletal muscle which mediate these changes by evaluating aerobic and resistance exercise-training induced changes: in basal and insulin-stimulated microvascular blood volume (using contrast-enhanced ultrasound); skeletal muscle mitochondrial function; and lipid droplet morphology and spatial interaction with mitochrondria, muscle fibre capillarisation, endothelial content of key enzymes controlling dilation/constriction and GLUT-4 translocation (using confocal immunofluorescence microscopy and transmission electron microscopy methods). Thus, this work will integrate physiological and molecular data to determine the extent to which exercise training can improve insulin sensitivity in SA and the mechanisms underpinning this improvement. This knowledge is important for optimising diabetes prevention interventions in SAs and identification of potential novel therapeutic targets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants assigned to the control arm of the study will be asked to maintain their normal dietary and exercise habits. |
| Aerobic exercise group | Experimental | Behavioral: Aerobic exercise programmeParticipants randomised to the aerobic exercise intervention will undertake a 12-week aerobic exercise training programme. |
| Resistance exercise group | Experimental | Behavioral: Resistance exercise programmeParticipants randomised to the resistance exercise intervention will undertake a 12-week aerobic exercise training programme. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise programmeParticipants 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. | Behavioural | Aerobic exercise group |
| Resistance exercise programmeParticipants 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. | Behavioural | Resistance exercise group |
Primary outcome
Whole-body Insulin sensitivity
Time frame: Change between baseline and 12 weeks.
Change in whole-body insulin sensitivity measured by hyperinsulinaemic-euglycaemic clamp.
16 secondary outcomes
Insulin-stimulated GLUT4 translocation
Time frame: Change between baseline and 12 weeks.
Microvascular blood volume
Time frame: Change between baseline and 12 weeks.
Muscle mitochondrial function
Time frame: Change between baseline and 12 weeks.
Lipid droplet content in skeletal muscle
Time frame: Change between baseline and 12 weeks.
Lipid droplet proximity to mitochondria in skeletal muscle
Time frame: Change between baseline and 12 weeks.
Microvascular density in skeletal muscle
Time frame: Change between baseline and 12 weeks.
Change in enzymes controlling insulin-mediated increases in perfusion in skeletal muscle
Time frame: Change between baseline and 12 weeks.
Maximal oxygen uptake
Time frame: Change between baseline and 12 weeks.
Muscle maximal voluntary contraction
Time frame: Change between baseline and 12 weeks.
Lower body muscle strength
Time frame: Change between baseline and 12 weeks.
Upper body muscle strength
Time frame: Change between baseline and 12 weeks.
Grip strength
Time frame: Change between baseline and 12 weeks.
Fat mass
Time frame: Change between baseline and 12 weeks.
Fat-free mass
Time frame: Change between baseline and 12 weeks.
Weight
Time frame: Change between baseline and 12 weeks.
Waist circumference
Time frame: Change between baseline and 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 33159841Marx 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Gill, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise programme and Resistance exercise programme in people with Insulin Resistance, run by University of Glasgow at 1 site in United Kingdom.
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 4 inclusion and 11 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: paused, as of the sponsor's last update on 8 Oct 2020. 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 United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body Insulin sensitivity (time frame: Change between baseline and 12 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 NCT04007926, which also lists 1 linked publication.
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 8 Oct 2020.