Forearm Immobilization, Metabolic Health, and Muscle Loss

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Forearm immobilization

• Registration Number: NCT03866512
• Lead Sponsor: University of Exeter

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

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 Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Study Start: 2019-05-10
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Results First Submitted: 2023-01-10
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Results First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-agonist during immobilization	Forearm immobilization	Oral ingestion of salbutamol during 2 days of forearm immobilization
Placebo ingestion during immobilization	Forearm immobilization	Oral ingestion of a placebo 2 days of forearm immobilization
Acipimox ingestion during immobilization	Forearm immobilization	Oral ingestion of Acipimox during 2 days of forearm immobilization

Primary Outcome Measures

Name	Time	Method
Percent Change in Forearm Glucose Uptake	During the steady-state phase of the insulin clamp (i.e. last 30 min)	Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions

Secondary Outcome Measures

Name	Time	Method
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)	Percent change in muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion

Trial Locations

Locations (1)

Royal Exeter & Devon NHS Foundation Trust; 🇬🇧 Exeter, Devon, United Kingdom