Forearm Immobilization, Metabolic Health, and Muscle Loss

NCT03866512 | Completed Results

• 2 other identifiers: 250839209198/Z/17/Z
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will investigate the impact of altered substrate availability on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percent Change in Forearm Glucose Uptake

  Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions

  During the steady-state phase of the insulin clamp (i.e. last 30 min)

Secondary Outcomes (1)

• Percent Change in Muscle Protein Synthesis

  In the fasted state (30 min before starting insulin clamp), and during the steady-state phase of the insulin clamp (i.e. last 30 min)

Study Arms (3)

Acipimox ingestion during immobilization

EXPERIMENTAL

Oral ingestion of Acipimox during 2 days of forearm immobilization

Behavioral: Forearm immobilization

B-agonist during immobilization

EXPERIMENTAL

Oral ingestion of salbutamol during 2 days of forearm immobilization

Behavioral: Forearm immobilization

Placebo ingestion during immobilization

PLACEBO COMPARATOR

Oral ingestion of a placebo 2 days of forearm immobilization

Behavioral: Forearm immobilization

Interventions

Forearm immobilization BEHAVIORAL

Two days of forearm immobilization

Acipimox ingestion during immobilization; B-agonist during immobilization; Placebo ingestion during immobilization

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females 18-40 years of age
• Body mass index between 18 and 27

You may not qualify if:

• Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
• Any diagnosed cardiovascular disease
• Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
• Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
• Regular use of nutritional supplements
• Metallic implants
• A personal or family history of thrombosis, epilepsy, seizures or schizophrenia
• Any previous motor disorders
• Any known disorders in lipid metabolism
• Any known disorders in muscle metabolism
• Known allergy for Acipimox, beta agonist, or other substances in the tablets
• Known sensitivity for sympathomimetic drugs
• Known hypokalaemia
• Presence of an ulcer in the stomach or gut and/or strong history of indigestion
• Known severe kidney problems

Sponsors & Collaborators

• University of Exeter: lead
• Wellcome Trust: collaborator

Study Sites (1)

Royal Exeter & Devon NHS Foundation Trust

Exeter, Devon, United Kingdom

Location

Results Point of Contact

• Title: Dr Marlou Dirks
• Organization: University of Exeter

m.dirks@exeter.ac.uk

+44 1392 725496

Study Officials

• Marlou Dirks, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study design
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 7, 2019
• Study Start: May 10, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)