Forearm Immobilization, Metabolic Health, and Muscle Loss

Healthy Clinical Trial

Official title:

The Impact of Acipimox and Salbutamol Supplementation on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866512
• Other study ID #: 250839
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2021
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Thirty-six healthy young volunteers will undergo 2 days of forearm immobilization combined with ingestion of one of two drug or placebo. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Pregnancy
• Unable to give consent

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Forearm immobilization
Two days of forearm immobilization

Locations

Country	Name	City	State
United Kingdom	Royal Exeter & Devon NHS Foundation Trust	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm glucose uptake	Insulin sensitivity, measured as forearm glucose uptake, under hyperinsulinaemic-euglycaemic conditions	During the steady-state phase of the insulin clamp (i.e. last 30 min)
Secondary	Muscle protein synthesis	Muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion	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)
Secondary	Forearm muscle volume	Forearm muscle volume measured via MRI	Following cast application, and immediately after 2 days of forearm immobilizaiton