NCT03800290

Brief Summary

The purpose of this study is to investigate the effect of two weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Jun 2019

Typical duration for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2021

Completed
Last Updated

December 1, 2022

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

December 6, 2018

Last Update Submit

November 28, 2022

Conditions

Healthy

Keywords

Beta-2 adrenergic agonistGlucose homeostasisSkeletal muscleHuman

Outcome Measures

Primary Outcomes (1)

  • Insulin-stimulated peripheral glucose disposal (Rd)

    Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated peripheral glucose disposal (Rd) during the high-insulin infusion step during the two-step hyperinsulinemic-euglycemic clamp.

    2 weeks

Secondary Outcomes (1)

  • Skeletal muscle GLUT4 translocation

    acute (4 hours) and long-term (2 weeks)

Other Outcomes (11)

  • Body weight/composition

    2 weeks

  • Plasma substrates

    Acute (4 hours) and long-term (1 and 2 weeks)

  • Heart rate

    Acute (4 hours) and long-term (1 and 2 weeks)

  • +8 more other outcomes

Study Arms (2)

Clenbuterol hydrochloride

EXPERIMENTAL

Subjects will ingest clenbuterol hydrochloride capsules (20 microgram/each) twice daily (40 microgram/day) for a maximum of 14 days. Subjects that received the clenbuterol hydrochloride capsules (at random) in the first study period will receive the placebo capsules during the second study period.

Drug: Clenbuterol Hydrochloride

Placebos

PLACEBO COMPARATOR

Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 14 days. Subjects that received the placebo capsules (at random) in the first study period will receive the clenbuterol hydrochloride capsules during the second study period.

Drug: Placebos

Interventions

Clenbuterol HydrochlorideDRUG

Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks.

Clenbuterol hydrochloride
PlacebosDRUG

Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.

Placebos

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian;
  • Male sex;
  • Age: 18-30
  • BMI: 18-25 kg/m2;
  • Normal physical activity levels;

You may not qualify if:

  • Cardiovascular diseases (determined by means of questionnaires, heart rate/blood pressure measurements)
  • Respiratory diseases (including asthma, bronchitis and COPD);
  • Unstable body weight (weight gain or loss \> 5 kg in the last three months);
  • Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
  • Excessive alcohol and/or drug abuse;
  • Hypokalaemia;
  • Hb \< 8.4 mmol/L;
  • Epilepsy;
  • Smoking;
  • Renal and/or liver insufficiency;
  • Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
  • Medication use known to hamper subject's safety during the study procedures;
  • Subjects who do not want to be informed about unexpected medical findings;
  • Subjects who do not want that their treating physician to be informed;
  • Inability to participate and/or complete the required measurements;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • van Beek SMM, Bruls YMH, Vanweert F, Fealy CE, Connell NJ, Schaart G, Moonen-Kornips E, Jorgensen JA, Vaz FM, Smeets ETHC, Joris PJ, Gemmink A, Houtkooper RH, Hesselink MKC, Bengtsson T, Havekes B, Schrauwen P, Hoeks J. Effect of beta2-agonist treatment on insulin-stimulated peripheral glucose disposal in healthy men in a randomised placebo-controlled trial. Nat Commun. 2023 Jan 12;14(1):173. doi: 10.1038/s41467-023-35798-5.

    PMID: 36635304DERIVED

Study Officials

  • Joris Hoeks, PhD

    principle investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, double-blinded, placebo-controlled, cross-over, single-center study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

January 11, 2019

Study Start

June 1, 2019

Primary Completion

April 23, 2021

Study Completion

April 23, 2021

Last Updated

December 1, 2022

Record last verified: 2020-07

Locations

NL(1)