Pre DiabetesNCT03804892
Can Brisk Walking Combined With Ingestion of a Lipid-lowering Drug Improve Fat Metabolism in Muscle?
A study testing Body Composition, Maximal aerobic fitness test and Oral glucose tolerance test in people with Pre Diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
Briefly, participants will be assessed for their eligibility for the study using an oral glucose tolerance test, which involves drinking a sugary drink followed by a series of small blood samples. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Body Composition, Maximal aerobic fitness test and Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to Dec 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 25-55 years
- Overweight or obese (BMI >28 kg.m-2)
- Have prediabetes
- 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 intending to get pregnant during the study) 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 programmes 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
Briefly, participants will be assessed for their eligibility for the study using an oral glucose tolerance test, which involves drinking a sugary drink followed by a series of small blood samples. If eligible, participants will be asked to take part in a fitness test and then two trials which will involve walking on a treadmill at a steady pace. Before and after the exercise a small piece of muscle will be taken from their thigh under local anaesthesia, as well as several small blood samples. Muscle muscle samples will be assessed for lipid metabolites.
Read the detailed description
The accumulation of fat in skeletal muscle is linked with insulin resistance in obesity and T2D. However, fat also accumulates in the muscle of lean, healthy people, but they remain insulin sensitive. This is because healthy people are able to burn this fat to generate energy during exercise. However, overweight/obese inactive people can't use muscle fat during exercise in the same manner, which is related to the high blood lipid concentrations that are observed in these individuals. Acipimox is a lipid-lowering agent that specifically reduces the breakdown of fat in adipose tissue and has been shown improve the blood lipid profile of obese individuals and T2D patients, at least in the short-term (1-2 weeks). Previous research has shown that the combination of Acipimox with exercise restores the ability of obese people to burn fat during moderate-intensity cycling exercise. It is now important to test whether Acipimox also increases the ability to burn muscle fat during low-intensity walking in people with prediabetes. If it does, then the next step will be to test whether the combination of Acipimox and walking can lead to improved insulin sensitivity and reduced T2D risk over a longer intervention programme. Twelve people with pre-diabetes will be recruited to undertake two experimental trials in a randomised order. Each trial will involve walking for 45 minutes on a treadmill, with muscle biopsies obtained from the thigh before (basal), immediately following (post-exercise) and 3 h post-exercise. Each trial will be identical, except that participants will ingest either Acipimox or a placebo in a double-blind design. Muscle biopsies will be used to examine differences in muscle fat between the two trials.
- Conditions
- Pre Diabetes
- Being tested
- Body Composition, Maximal aerobic fitness test, Oral glucose tolerance test, Muscle biopsy, Blood samples
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body CompositionDiagnostic test
Participants undergo a 5 minute body scan to determine their body composition.
Maximal aerobic fitness testDiagnostic test
Participants will complete a walking fitness text until exhaustion to determine maximal aerobic capacity.
Oral glucose tolerance testDiagnostic test
Participants will undergo an OGTT to determine insulin sensitivity.
Muscle biopsyOther
Participants will give a small muscle sample pre-, immediately post and 3 hours post- the exercise trial to be assessed for lipid metabolites.
Blood samplesOther
Participants will give 16 blood samples, to be assessed for fatty acids in the blood.
| Study group | Role | What they receive |
|---|---|---|
| Acipimox ingestion | Experimental | Participants will undergo pre assessment testing of a body composition (DEXA), a maximal aerobic fitness test, and an oral glucose tolerance test. Following this, participants will ingest 250 mg of Acipimox, before undertaking 45 minutes walking on a treadmill. A muscle biopsy will be taken pre, immediately post and 3 hours post the walking trial. Blood samples will be taken at regular intervals throughout. Receives: Diagnostic Test: Body Composition; Diagnostic Test: Maximal aerobic fitness test; Diagnostic Test: Oral glucose tolerance test; Other: Muscle biopsy; Other: Blood samples |
| No drug | Other | Participants will undergo pre assessment testing of a body composition (DEXA), a maximal aerobic fitness test, and an oral glucose tolerance test.Participants will then undergo a 45 minute walk on a treadmill with no Acipimox ingestion. A muscle biopsy will be taken pre, immediately post and 3 hours post the walking trial. Blood samples will be taken at regular intervals throughout. Receives: Diagnostic Test: Body Composition; Diagnostic Test: Maximal aerobic fitness test; Diagnostic Test: Oral glucose tolerance test; Other: Muscle biopsy; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma fatty acids levels
Blood samples will be assessed for the amount of fatty acids in the blood.
Measured: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.
Skeletal muscle Diacylglycerol (DAG) levels
Muscle biopsies will be assessed for lipid metabolites using liquid chromatography-mass spectrometry.
Measured: A change from baseline DAGs to DAGS immediately post and 3 hours post exercise trial.
Plasma Glycerol levels
Blood samples will be assessed for the amount of glycerol in the blood throughout the exercise trial.
Measured: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.
IMTG utilisation during exercise
Muscle samples will be analysed using confocal immunofluorescence microscopy for the amount of IMTG within the samples.
Measured: A change in amount of IMTG within the muscle from baseline, to immediately post and 3 hours post the exercise intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Oct 2019
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Crossover
- Model description
- This study involves 2 trials. Each trial will involve walking for 45 minutes on a treadmill, with muscle biopsies obtained from the thigh before (basal), immediately following (post-exercise) and 3 h post-exercise. Each trial will be identical, except that participants will ingest either Acipimox or a placebo in a double-blind design. Muscle biopsies will be used to examine differences in muscle fat between the two trials
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
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, L3 3AF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804892
- Sponsor's protocol ID
- 249734
- 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 Brisk Walking Combined With Ingestion of a Lipid-lowering Drug Improve Fat Metabolism in Muscle?
- ClinicalTrials.gov ID
- NCT03804892
- Acronym / sponsor ID
- 249734
- Conditions
- Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Diabetes UK, Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool University Hospital
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 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.
Briefly, participants will be assessed for their eligibility for the study using an oral glucose tolerance test, which involves drinking a sugary drink followed by a series of small blood samples. If eligible, participants will be asked to take part in a fitness test and then two trials which will involve walking on a treadmill at a steady pace. Before and after the exercise a small piece of muscle will be taken from their thigh under local anaesthesia, as well as several small blood samples. Muscle muscle samples will be assessed for lipid metabolites.
Detailed description
The accumulation of fat in skeletal muscle is linked with insulin resistance in obesity and T2D. However, fat also accumulates in the muscle of lean, healthy people, but they remain insulin sensitive. This is because healthy people are able to burn this fat to generate energy during exercise. However, overweight/obese inactive people can't use muscle fat during exercise in the same manner, which is related to the high blood lipid concentrations that are observed in these individuals. Acipimox is a lipid-lowering agent that specifically reduces the breakdown of fat in adipose tissue and has been shown improve the blood lipid profile of obese individuals and T2D patients, at least in the short-term (1-2 weeks). Previous research has shown that the combination of Acipimox with exercise restores the ability of obese people to burn fat during moderate-intensity cycling exercise. It is now important to test whether Acipimox also increases the ability to burn muscle fat during low-intensity walking in people with prediabetes. If it does, then the next step will be to test whether the combination of Acipimox and walking can lead to improved insulin sensitivity and reduced T2D risk over a longer intervention programme. Twelve people with pre-diabetes will be recruited to undertake two experimental trials in a randomised order. Each trial will involve walking for 45 minutes on a treadmill, with muscle biopsies obtained from the thigh before (basal), immediately following (post-exercise) and 3 h post-exercise. Each trial will be identical, except that participants will ingest either Acipimox or a placebo in a double-blind design. Muscle biopsies will be used to examine differences in muscle fat between the two trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study involves 2 trials. Each trial will involve walking for 45 minutes on a treadmill, with muscle biopsies obtained from the thigh before (basal), immediately following (post-exercise) and 3 h post-exercise. Each trial will be identical, except that participants will ingest either Acipimox or a placebo in a double-blind design. Muscle biopsies will be used to examine differences in muscle fat between the two trials
| Arm | Type | Receives |
|---|---|---|
| Acipimox ingestion | Experimental | Diagnostic Test: Body Composition, Diagnostic Test: Maximal aerobic fitness test, Diagnostic Test: Oral glucose tolerance test, Other: Muscle biopsy, Other: Blood samplesParticipants will undergo pre assessment testing of a body composition (DEXA), a maximal aerobic fitness test, and an oral glucose tolerance test. Following this, participants will ingest 250 mg of Acipimox, before undertaking 45 minutes walking on a treadmill. A muscle biopsy will be taken pre, immediately post and 3 hours post the walking trial. Blood samples will be taken at regular intervals throughout. |
| No drug | Other | Diagnostic Test: Body Composition, Diagnostic Test: Maximal aerobic fitness test, Diagnostic Test: Oral glucose tolerance test, Other: Muscle biopsy, Other: Blood samplesParticipants will undergo pre assessment testing of a body composition (DEXA), a maximal aerobic fitness test, and an oral glucose tolerance test.Participants will then undergo a 45 minute walk on a treadmill with no Acipimox ingestion. A muscle biopsy will be taken pre, immediately post and 3 hours post the walking trial. Blood samples will be taken at regular intervals throughout. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 25-55 years
- Overweight or obese (BMI >28 kg.m-2)
- Have prediabetes
- Not currently using any anti-diabetes medication
- Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
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 programmes 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 |
|---|---|---|
| Body CompositionParticipants undergo a 5 minute body scan to determine their body composition. | Diagnostic test | Acipimox ingestion, No drug |
| Maximal aerobic fitness testParticipants will complete a walking fitness text until exhaustion to determine maximal aerobic capacity. | Diagnostic test | Acipimox ingestion, No drug |
| Oral glucose tolerance testParticipants will undergo an OGTT to determine insulin sensitivity. | Diagnostic test | Acipimox ingestion, No drug |
| Muscle biopsyParticipants will give a small muscle sample pre-, immediately post and 3 hours post- the exercise trial to be assessed for lipid metabolites. | Other | Acipimox ingestion, No drug |
| Blood samplesParticipants will give 16 blood samples, to be assessed for fatty acids in the blood. | Other | Acipimox ingestion, No drug |
Primary outcome
Plasma fatty acids levels
Time frame: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.
Blood samples will be assessed for the amount of fatty acids in the blood.
Skeletal muscle Diacylglycerol (DAG) levels
Time frame: A change from baseline DAGs to DAGS immediately post and 3 hours post exercise trial.
Muscle biopsies will be assessed for lipid metabolites using liquid chromatography-mass spectrometry.
Plasma Glycerol levels
Time frame: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.
Blood samples will be assessed for the amount of glycerol in the blood throughout the exercise trial.
IMTG utilisation during exercise
Time frame: A change in amount of IMTG within the muscle from baseline, to immediately post and 3 hours post the exercise intervention.
Muscle samples will be analysed using confocal immunofluorescence microscopy for the amount of IMTG within the samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- 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.
Jennifer S Barrett, PhD principal investigator
Liverpool John Moores University, L3 3AF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Composition, Maximal aerobic fitness test and Oral glucose tolerance test 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 8 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: status not confirmed, 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. 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?
Plasma fatty acids levels (time frame: A change in the amount of fatty acids in the blood from baseline, to every 15 minute interval from the ingestion of acipimox up until 2 hours 45 minutes. From this point, samples will be every 30 minutes until 3 hours 45 minutes terminates the trial.). The study lists 4 primary outcomes in all. 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.