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

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. 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.

Conditions

• Pre-diabetes

Interventions

OTHER

Exercise Program

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

DIAGNOSTIC_TEST

DXA

Participants will undergo an assessment of body composition (DXA)

DIAGNOSTIC_TEST

MRI

used to measure fat stored in the liver

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.

DIAGNOSTIC_TEST

VO2 Max

Assessment of maximum aerobic capacity.

DIAGNOSTIC_TEST

Continuous Glucose Monitor

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

PROCEDURE

Muscle Biopsies

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

DRUG

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.

Sponsors & Collaborators

• Diabetes UK

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Royal Liverpool University Hospital

  collaborator OTHER_GOV

• Liverpool John Moores University

  lead OTHER

Principal Investigators

• Jennifer s Barrett, PhD · Liverpool John Moores University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-06

Primary Completion

2023-07-31

Completion

2023-07-31

Countries

• United Kingdom

Study Locations