Forearm Immobilization, Metabolic Health, and Muscle Loss

• Sponsor: University of Exeter (Other)
• Overall Status: Completed
• CT.gov ID: NCT03866512
• Collaborator: Wellcome Trust (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 25.7
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Forearm immobilization	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind study design
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: May 10, 2019
• Actual Primary Completion Date: Jul 1, 2021
• Actual Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acipimox ingestion during immobilization Oral ingestion of Acipimox during 2 days of forearm immobilization	Behavioral: Forearm immobilization; Two days of forearm immobilization
Experimental: B-agonist during immobilization Oral ingestion of salbutamol during 2 days of forearm immobilization	Behavioral: Forearm immobilization; Two days of forearm immobilization
Placebo Comparator: Placebo ingestion during immobilization Oral ingestion of a placebo 2 days of forearm immobilization	Behavioral: Forearm immobilization; Two days of forearm immobilization

Outcome Measures

Primary Outcome Measures

1. Forearm glucose uptake [During the steady-state phase of the insulin clamp (i.e. last 30 min)]

   Insulin sensitivity, measured as forearm glucose uptake, under hyperinsulinaemic-euglycaemic conditions

Secondary Outcome Measures

1. 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)]

   Muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion

2. Forearm muscle volume [Following cast application, and immediately after 2 days of forearm immobilizaiton]

   Forearm muscle volume measured via MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Exeter & Devon NHS Foundation Trust	Exeter	Devon	United Kingdom

Sponsors and Collaborators

• University of Exeter
• Wellcome Trust

Investigators

• Principal Investigator: Marlou Dirks, PhD, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Exeter
• ClinicalTrials.gov Identifier: NCT03866512
• Other Study ID Numbers: 250839
• First Posted: Mar 7, 2019
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Oct 13, 2021