Pre-diabetesNCT03809793
Can the Health Benefits of a Walking-based Exercise Programme be Enhanced by Co-ingestion of a Lipid-lowering Drug?
A study testing Exercise Program, DXA and MRI in people with Pre-diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
Study investigates the hypothesis that an exercise programme of steady walking will have larger effects on insulin sensitivity and glycemic control when combined with Acipimox intake prior to each exercise session in people with pre-diabetes. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Exercise Program, DXA and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to 31 Jul 2023
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI >28 kg.m-2
- Pre-diabetic
- Not currently using any anti-diabetes medication
- Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
- Not pregnant or currently breast feeding
- Pre-menopausal
- Not currently involved in a weight loss programme or using weight loss medication
Who cannot join
- Involved in regular exercise (engaged in more than 2 sessions of structured exercise of >30 min per week)
- Currently using anti-diabetes medication (e.g. insulin, metformin)
- Currently using niacin/vitamin B3 supplements
- Pregnant or breast feeding
- Currently engaged in active weight loss programme or using weight loss medication
- Diagnosed with chronic kidney disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L18 8EU
About this study
Study investigates the hypothesis that an exercise programme of steady walking will have larger effects on insulin sensitivity and glycemic control when combined with Acipimox intake prior to each exercise session in people with pre-diabetes. Thirty-four sedentary, overweight/obese people (aged 25-50 years, BMI >28 kg.m-2) with pre-diabetes will be recruited using the same strategy as study 2 and split into two groups (detailed below). Participants will undergo several pre- intervention assessments, followed by a 12-week walking based intervention combined with either Acipimox ingestion or no drug ingestion, pre- each exercise session. Following this, the post-assessment measures will identical to the pre-assessment measures.
Read the detailed description
Study 3 investigates the hypothesis that an exercise programme of steady walking will have larger effects on insulin sensitivity and glycaemic control when combined with Acipimox intake prior to each exercise session in people with prediabetes. Thirty-four sedentary, overweight/obese people (aged 25-50 years, BMI >28 kg.m-2) with prediabetes will be recruited using the same strategy as study 2 and split into two groups (detailed below).
Pre-intervention assessments:
Visit 1: Participants will undergo an assessment of body composition (DXA) and undertake a graded treadmill walking test to estimate maximal aerobic fitness (VO2max).
Visit 2: Participants will be able to opt to undergo an MRI scan, taking place before breakfast. The MRI scan is used to measure fat stored in the liver and muscles. A continuous glucose monitoring (CGM) sensor will be inserted to measure insulin sensitivity.
Visit 3: Participants will arrive at the laboratory after an overnight fast (>10 h) to undergo a Hyperinsulinaemic euglycaemic clamp to assess whole-body insulin sensitivity. Plasma glucose will be measured at regular intervals and muscle biopsies will be obtained from the vastus lateralis muscle of one leg before and after 2 hours of the clamp.
Exercise intervention: Pairs of participants from each group (matched for gender, age and VO2max) will be randomized to undertake 12 weeks of steady walking combined with ingestion of either Acipimox or placebo in a counter-balanced, double-blind design. Supervised treadmill walking sessions will be undertaken at LJMU three times per week, with exercise performed at a speed equivalent to 45% VO2max. Participants will initially exercise for 30 mins per session (weeks 1 and 2), and each session will increase in duration by 5 mins every 2 weeks thereafter, up to 50 minutes of exercise. 1 hour before each walking session, participants will ingest either 250 mg Acipimox or nothing.
Post-intervention assessments: The post-intervention assessments will be identical in all respects to the pre-intervention assessments and will be commenced ≥72 hours after the final training session.
- Conditions
- Pre-diabetes
- Being tested
- Exercise Program, DXA, MRI, Hyperinsulinaemic Euglycaemic Clamp, VO2 Max
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
12-week walking based intervention (3 sessions per week)
DXADiagnostic test
Participants will undergo an assessment of body composition (DXA)
MRIDiagnostic test
used to measure fat stored in the liver
Hyperinsulinaemic Euglycaemic ClampDiagnostic test
Participants will arrive at the laboratory after an overnight fast (>10 h) to undergo a Hyperinsulinaemic euglycaemic clamp to assess whole-body insulin sensitivity. Plasma glucose will be measured at regular intervals and muscle biopsies will be obtained from the vastus lateralis muscle of one leg before and after 2 hours of the clamp.
VO2 MaxDiagnostic test
Assessment of maximum aerobic capacity.
Continuous Glucose MonitorDiagnostic test
CGM sensor will be inserted to measure insulin sensitivity over a 24hr period.
Muscle BiopsiesProcedure or surgery
Participants will undergo muscle biopsies pre and post the hyperinsulinemic euglyceamic clamp from the vastus lateralis.
Acipimox 250 MGDrug
Participants will be randomised into two groups. One group will be prescribed Acipimox that will be taken 1 hour prior to each exercise session. The other group will take no drug.
| Study group | Role | What they receive |
|---|---|---|
| Acipimox ingestion | Active comparator | Individuals in this group will undergo pre-assessments for body composition (DXA), Insulin sensitivity (Hyperinsulinaemic Euglycaemic clamp and continuous glucose monitor), muscle biopsies pre- and post- clamp for analysis of lipid metabolites, liver fat (MRI) and exercise capacity (VO2 max). Participants will then ingest 250 mg of Acipimox 1 hour before each exercise session of the 12 week intervention. Receives: Other: Exercise Program; Diagnostic Test: DXA; Diagnostic Test: MRI; Diagnostic Test: Hyperinsulinaemic Euglycaemic Clamp; Diagnostic Test: VO2 Max; Diagnostic Test: Continuous Glucose Monitor; Procedure: Muscle Biopsies; Drug: Acipimox 250 MG |
| No drug | Placebo comparator | Individuals in this group will undergo pre-assessments for body composition (DXA), Insulin sensitivity (Hyperinsulinaemic Euglycaemic clamp and continuous glucose monitor) with muscle biopsies pre- and post- clamp for analysis of lipid metabolites, liver fat (MRI) and exercise capacity (VO2 max). Participants will then ingest nothing prior to their exercise sessions during the 12-week exercise programme. Receives: Other: Exercise Program; Diagnostic Test: DXA; Diagnostic Test: MRI; Diagnostic Test: Hyperinsulinaemic Euglycaemic Clamp; Diagnostic Test: VO2 Max; Diagnostic Test: Continuous Glucose Monitor; Procedure: Muscle Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
A pre- and post- hyperinsulinaemic euglycaemic clamp will assess changes in whole body insulin sensitivity.
Measured: A change in insulin sensitivity from baseline will be compared to week 12.
Secondary outcomes (4)
Sub-maximal VO2 walking test
Participants will be assessed for pre- and post- maximal aerobic capacity.
Measured: A change in aerobic capacity (VO2) from baseline will be compared to week 12.
Percentage of Liver Fat
A pre- and post- intervention MRI scan will show any changes in Liver Fat
Measured: The change percentage of liver fat will be measured at baseline and be compared to value at the end of week 12.
Changes in Intramuscular GLUT4
Muscle biopsy samples will undergo analysis of mechanisms for insulin sensitivity and lipid metabolites using confocal immunofluorescence microscopy.
Measured: A change in the co-localisation of GLUT4 will be assessed from the values from the clamp at baseline, to the clamp at week 12 after the intervention.
Change in intramuscular DAGs
The amount of DAGs within the muscle will be analysed using liquid chromatography-mass spectrometry.
Measured: A change in the amount of DAGs will be assessed from the values from the clamp at baseline, to the clamp at week 12 after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start6 Jan 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies 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
- 34 pre-diabetics will be split into 2 groups; one will ingest Acipimox for 12-weeks and the other will ingest nothing.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK, Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool University Hospital
- Responsible party
- Principal investigator, Jennifer Barrett, Liverpool John Moores University
- Investigators
- Jennifer s Barrett, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809793
- Sponsor's protocol ID
- 250408
- Status last verified
- Dec 2023
- First submitted
- 7 Jan 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Health Benefits of a Walking-based Exercise Programme be Enhanced by Co-ingestion of a Lipid-lowering Drug?
- ClinicalTrials.gov ID
- NCT03809793
- Acronym / sponsor ID
- 250408
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Diabetes UK, Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool University Hospital
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Jan 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.
Study investigates the hypothesis that an exercise programme of steady walking will have larger effects on insulin sensitivity and glycemic control when combined with Acipimox intake prior to each exercise session in people with pre-diabetes. Thirty-four sedentary, overweight/obese people (aged 25-50 years, BMI >28 kg.m-2) with pre-diabetes will be recruited using the same strategy as study 2 and split into two groups (detailed below). Participants will undergo several pre- intervention assessments, followed by a 12-week walking based intervention combined with either Acipimox ingestion or no drug ingestion, pre- each exercise session. Following this, the post-assessment measures will identical to the pre-assessment measures.
Detailed description
Study 3 investigates the hypothesis that an exercise programme of steady walking will have larger effects on insulin sensitivity and glycaemic control when combined with Acipimox intake prior to each exercise session in people with prediabetes. Thirty-four sedentary, overweight/obese people (aged 25-50 years, BMI >28 kg.m-2) with prediabetes will be recruited using the same strategy as study 2 and split into two groups (detailed below).
Pre-intervention assessments:
Visit 1: Participants will undergo an assessment of body composition (DXA) and undertake a graded treadmill walking test to estimate maximal aerobic fitness (VO2max).
Visit 2: Participants will be able to opt to undergo an MRI scan, taking place before breakfast. The MRI scan is used to measure fat stored in the liver and muscles. A continuous glucose monitoring (CGM) sensor will be inserted to measure insulin sensitivity.
Visit 3: Participants will arrive at the laboratory after an overnight fast (>10 h) to undergo a Hyperinsulinaemic euglycaemic clamp to assess whole-body insulin sensitivity. Plasma glucose will be measured at regular intervals and muscle biopsies will be obtained from the vastus lateralis muscle of one leg before and after 2 hours of the clamp.
Exercise intervention: Pairs of participants from each group (matched for gender, age and VO2max) will be randomized to undertake 12 weeks of steady walking combined with ingestion of either Acipimox or placebo in a counter-balanced, double-blind design. Supervised treadmill walking sessions will be undertaken at LJMU three times per week, with exercise performed at a speed equivalent to 45% VO2max. Participants will initially exercise for 30 mins per session (weeks 1 and 2), and each session will increase in duration by 5 mins every 2 weeks thereafter, up to 50 minutes of exercise. 1 hour before each walking session, participants will ingest either 250 mg Acipimox or nothing.
Post-intervention assessments: The post-intervention assessments will be identical in all respects to the pre-intervention assessments and will be commenced ≥72 hours after the final training session.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 34 pre-diabetics will be split into 2 groups; one will ingest Acipimox for 12-weeks and the other will ingest nothing.
| Arm | Type | Receives |
|---|---|---|
| Acipimox ingestion | Active comparator | Other: Exercise Program, Diagnostic Test: DXA, Diagnostic Test: MRI, Diagnostic Test: Hyperinsulinaemic Euglycaemic Clamp, Diagnostic Test: VO2 Max, Diagnostic Test: Continuous Glucose Monitor, Procedure: Muscle Biopsies, Drug: Acipimox 250 MGIndividuals in this group will undergo pre-assessments for body composition (DXA), Insulin sensitivity (Hyperinsulinaemic Euglycaemic clamp and continuous glucose monitor), muscle biopsies pre- and post- clamp for analysis of lipid metabolites, liver fat (MRI) and exercise capacity (VO2 max). Participants will then ingest 250 mg of Acipimox 1 hour before each exercise session of the 12 week intervention. |
| No drug | Placebo comparator | Other: Exercise Program, Diagnostic Test: DXA, Diagnostic Test: MRI, Diagnostic Test: Hyperinsulinaemic Euglycaemic Clamp, Diagnostic Test: VO2 Max, Diagnostic Test: Continuous Glucose Monitor, Procedure: Muscle BiopsiesIndividuals in this group will undergo pre-assessments for body composition (DXA), Insulin sensitivity (Hyperinsulinaemic Euglycaemic clamp and continuous glucose monitor) with muscle biopsies pre- and post- clamp for analysis of lipid metabolites, liver fat (MRI) and exercise capacity (VO2 max). Participants will then ingest nothing prior to their exercise sessions during the 12-week exercise programme. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI >28 kg.m-2
- Pre-diabetic
- Not currently using any anti-diabetes medication
- Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
- Not pregnant or currently breast feeding
Key exclusion criteria (6 listed)
- Involved in regular exercise (engaged in more than 2 sessions of structured exercise of >30 min per week)
- Currently using anti-diabetes medication (e.g. insulin, metformin)
- Currently using niacin/vitamin B3 supplements
- Pregnant or breast feeding
- Currently engaged in active weight loss programme or using weight loss medication
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 |
|---|---|---|
| Exercise Program12-week walking based intervention (3 sessions per week) | Other | Acipimox ingestion, No drug |
| DXAParticipants will undergo an assessment of body composition (DXA) | Diagnostic test | Acipimox ingestion, No drug |
| MRIused to measure fat stored in the liver | Diagnostic test | Acipimox ingestion, No drug |
| Hyperinsulinaemic Euglycaemic ClampParticipants will arrive at the laboratory after an overnight fast (>10 h) to undergo a Hyperinsulinaemic euglycaemic clamp to assess whole-body insulin sensitivity. Plasma glucose will be measured at regular intervals and muscle biopsies will be obtained from the vastus lateralis muscle of one leg before and after 2 hours of the clamp. | Diagnostic test | Acipimox ingestion, No drug |
| VO2 MaxAssessment of maximum aerobic capacity. | Diagnostic test | Acipimox ingestion, No drug |
| Continuous Glucose MonitorCGM sensor will be inserted to measure insulin sensitivity over a 24hr period. | Diagnostic test | Acipimox ingestion, No drug |
| Muscle BiopsiesParticipants will undergo muscle biopsies pre and post the hyperinsulinemic euglyceamic clamp from the vastus lateralis. | Procedure or surgery | Acipimox ingestion, No drug |
| Acipimox 250 MGParticipants will be randomised into two groups. One group will be prescribed Acipimox that will be taken 1 hour prior to each exercise session. The other group will take no drug. | Drug | Acipimox ingestion |
Primary outcome
Insulin Sensitivity
Time frame: A change in insulin sensitivity from baseline will be compared to week 12.
A pre- and post- hyperinsulinaemic euglycaemic clamp will assess changes in whole body insulin sensitivity.
4 secondary outcomes
Sub-maximal VO2 walking test
Time frame: A change in aerobic capacity (VO2) from baseline will be compared to week 12.
Percentage of Liver Fat
Time frame: The change percentage of liver fat will be measured at baseline and be compared to value at the end of week 12.
Changes in Intramuscular GLUT4
Time frame: A change in the co-localisation of GLUT4 will be assessed from the values from the clamp at baseline, to the clamp at week 12 after the intervention.
Change in intramuscular DAGs
Time frame: A change in the amount of DAGs will be assessed from the values from the clamp at baseline, to the clamp at week 12 after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pre-diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
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.
Jennifer s Barrett, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program, DXA and MRI in people with Pre-diabetes, run by Liverpool John Moores University 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin Sensitivity (time frame: A change in insulin sensitivity from baseline will be compared to week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.