HealthyPhase 2NCT03800290
Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake
A Phase 2 study testing Clenbuterol Hydrochloride in people with Healthy, run by Maastricht University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clenbuterol Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2019to 23 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian;
- Male sex;
- Age: 18-30
- BMI: 18-25 kg/m2;
- Normal physical activity levels;
Who cannot join
- Not meeting all inclusion criteria
- 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;
Show all 19Show fewer
- 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;
- Participation in organised or structured physical exercise;
- Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;
- Hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Healthy Humans
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.
- Conditions
- Healthy
- Being tested
- Clenbuterol Hydrochloride, Placebos
- Keywords
- Beta-2 adrenergic agonist, Glucose homeostasis, Skeletal muscle, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlacebosDrug
Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
Skeletal muscle GLUT4 translocation
Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle GLUT4 translocation as assessed by means of wide-field microscopy in skeletal muscle biopsies
Measured: acute (4 hours) and long-term (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Jun 2019
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over, single-center study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joris Hoeks, PhD, Principal investigator, principle investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800290
- Sponsor's protocol ID
- NL67646.068.18
- Status last verified
- Jul 2020
- First submitted
- 6 Dec 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36635304
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Beta-2-adrenergic Pathway to Improve Skeletal Muscle Glucose Uptake in Healthy Humans
- ClinicalTrials.gov ID
- NCT03800290
- Acronym / sponsor ID
- NL67646.068.18
- Conditions
- Healthy
- Keywords
- Beta-2 adrenergic agonist, Glucose homeostasis, Skeletal muscle, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over, single-center study
| Arm | Type | Receives |
|---|---|---|
| Clenbuterol hydrochloride | Experimental | Drug: Clenbuterol HydrochlorideSubjects 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. |
| Placebos | Placebo comparator | Drug: PlacebosSubjects 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian;
- Male sex;
- Age: 18-30
- BMI: 18-25 kg/m2;
- Normal physical activity levels;
Key exclusion criteria (19 listed)
- Not meeting all inclusion criteria
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clenbuterol HydrochlorideDaily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks. | Drug | Clenbuterol hydrochloride |
| PlacebosDaily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks. | Drug | Placebos |
Primary outcome
Insulin-stimulated peripheral glucose disposal (Rd)
Time frame: 2 weeks
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.
1 secondary outcome
Skeletal muscle GLUT4 translocation
Time frame: acute (4 hours) and long-term (2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 36635304van 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Hoeks, PhD principal investigator
principle investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clenbuterol Hydrochloride in people with Healthy, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-stimulated peripheral glucose disposal (Rd) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.