Overview

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

Status:
Suspended
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Liverpool John Moores University
Collaborators:
Aintree University Hospitals NHS Foundation Trust
Diabetes UK
Liverpool University Hospitals NHS Foundation Trust
Royal Liverpool University Hospital
Treatments:
Acipimox
Hypolipidemic Agents
Insulin
Insulin, Globin Zinc
Criteria
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