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Forearm Immobilization, Metabolic Health, and Muscle Loss

U

University of Exeter

Status

Completed

Conditions

Healthy

Treatments

Behavioral: Forearm immobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT03866512
209198/Z/17/Z (Other Grant/Funding Number)
250839

Details and patient eligibility

About

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

Full 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.

Enrollment

37 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

37 participants in 3 patient groups, including a placebo group

Acipimox ingestion during immobilization
Experimental group
Description:
Oral ingestion of Acipimox during 2 days of forearm immobilization
Treatment:
Behavioral: Forearm immobilization
B-agonist during immobilization
Experimental group
Description:
Oral ingestion of salbutamol during 2 days of forearm immobilization
Treatment:
Behavioral: Forearm immobilization
Placebo ingestion during immobilization
Placebo Comparator group
Description:
Oral ingestion of a placebo 2 days of forearm immobilization
Treatment:
Behavioral: Forearm immobilization

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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