Can the Health Benefits of a Walking-based Exercise Programme be Enhanced by Co-ingestion of a Lipid-lowering Drug?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

34 pre-diabetics will be split into 2 groups; one will ingest Acipimox for 12-weeks and the other will ingest nothing.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

both participants and investigators will know if they are ingesting Acipimox or nothing.

Study Groups

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Acipimox ingestion

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.

Group Type ACTIVE_COMPARATOR

Exercise Program

Intervention Type OTHER

12-week walking based intervention (3 sessions per week)

DXA

Intervention Type DIAGNOSTIC_TEST

Participants will undergo an assessment of body composition (DXA)

MRI

Intervention Type DIAGNOSTIC_TEST

used to measure fat stored in the liver

Hyperinsulinaemic Euglycaemic Clamp

Intervention Type DIAGNOSTIC_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 Max

Intervention Type DIAGNOSTIC_TEST

Assessment of maximum aerobic capacity.

Continuous Glucose Monitor

Intervention Type DIAGNOSTIC_TEST

CGM sensor will be inserted to measure insulin sensitivity over a 24hr period.

Muscle Biopsies

Intervention Type PROCEDURE

Participants will undergo muscle biopsies pre and post the hyperinsulinemic euglyceamic clamp from the vastus lateralis.

Acipimox 250 MG

Intervention Type DRUG

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.

No drug

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.

Group Type PLACEBO_COMPARATOR

Exercise Program

Intervention Type OTHER

12-week walking based intervention (3 sessions per week)

DXA

Intervention Type DIAGNOSTIC_TEST

Participants will undergo an assessment of body composition (DXA)

MRI

Intervention Type DIAGNOSTIC_TEST

used to measure fat stored in the liver

Hyperinsulinaemic Euglycaemic Clamp

Intervention Type DIAGNOSTIC_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 Max

Intervention Type DIAGNOSTIC_TEST

Assessment of maximum aerobic capacity.

Continuous Glucose Monitor

Intervention Type DIAGNOSTIC_TEST

CGM sensor will be inserted to measure insulin sensitivity over a 24hr period.

Muscle Biopsies

Intervention Type PROCEDURE

Participants will undergo muscle biopsies pre and post the hyperinsulinemic euglyceamic clamp from the vastus lateralis.

Interventions

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Exercise Program

12-week walking based intervention (3 sessions per week)

Intervention Type OTHER

DXA

Participants will undergo an assessment of body composition (DXA)

Intervention Type DIAGNOSTIC_TEST

MRI

used to measure fat stored in the liver

Intervention Type DIAGNOSTIC_TEST

Hyperinsulinaemic Euglycaemic Clamp

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.

Intervention Type DIAGNOSTIC_TEST

VO2 Max

Assessment of maximum aerobic capacity.

Intervention Type DIAGNOSTIC_TEST

Continuous Glucose Monitor

CGM sensor will be inserted to measure insulin sensitivity over a 24hr period.

Intervention Type DIAGNOSTIC_TEST

Muscle Biopsies

Participants will undergo muscle biopsies pre and post the hyperinsulinemic euglyceamic clamp from the vastus lateralis.

Intervention Type PROCEDURE

Acipimox 250 MG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No