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OpenTrials
Completed

NCT Number: NCT03866512

Forearm Immobilization, Metabolic Health, and Muscle Loss

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Exeter & Devon NHS Foundation Trust

Exeter, Devon, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forearm immobilization

Behavioral

Two days of forearm immobilization

Primary outcomes

  1. Percent Change in Forearm Glucose Uptake

    Time frame: 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 outcomes

  1. Percent Change in Muscle Protein Synthesis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Wellcome Trust

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2019
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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