Type 2 DiabetesPhase 2NCT04921306
Obese Human Beta-2-adrenergic Stimulation and Muscle Glucose Uptake
A Phase 2 study testing Clenbuterol Hydrochloride in people with Type 2 Diabetes, run by Maastricht University at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effect of four weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in overweight/obese male and (postmenopausal) female volunteers. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- 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
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Aug 2022to 1 Mar 2024
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian;
- Male or (postmenopausal; defined as 1 year after the last cycle) female;
- Age between 40-70 years;
- BMI: 27-35 kg/m2;
Who cannot join
- Not meeting all inclusion criteria
- Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)
- Respiratory diseases (including asthma, bronchitis and COPD);
- Unstable body weight (weight gain or loss > 3 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;
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- Hypokalaemia;
- Hyperthyroidism
- Anaemia;
- Epilepsy;
- Smoking;
- Renal and/or liver insufficiency;
- Diagnosed with type 1 or type 2 diabetes mellitus;
- Any contra-indications to MRI scanning. These contra-indications include patients with:
- Electronic implants such as pacemakers, defibrillators or neurostimulators
- Central nervous system aneurysm clip
- Some hearing aids (such as cochlear implant) and artificial (heart) valves which are contraindicated for MRI/MRS
- Iron containing corpora aliena in the eye or brains
- Claustrophobia
- 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 (>2h per week);
- 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;
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 Obese Humans
The purpose of this study is to investigate the effect of four weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in overweight/obese male and (postmenopausal) female volunteers.
- Conditions
- Type 2 Diabetes
- Being tested
- Clenbuterol Hydrochloride, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
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 28 days with a wash-out period of at least 6-8 weeks.
PlaceboDrug
Daily ingestion of placebo capsules for a total period of 28 days with a wash-out period of at least 6-8 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 28 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 |
| Placebo | Placebo comparator | Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 28 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: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.
Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in quadriceps muscle as assessed using radio-active labelled tracer (18F-FDG) in positron emission tomogaphy magnetic resonance imaging (PET-MRI).
Measured: 4 weeks
Secondary outcomes (1)
insulin-stimulated 18F-FDG uptake in BAT
Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in BAT as assessed using radio-active labelled tracer (18F-FDG) in PET-MRI.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start16 Aug 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 Type 2 DiabetesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Eurostars
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921306
- Sponsor's protocol ID
- NL76746.068.21
- Status last verified
- May 2024
- First submitted
- 25 May 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Lier PMG, van de Weijer T, Vanweert F, Brouwers K, Nijssen KMR, Schaart G, Moonen-Kornips E, van Beek SMM, Springer S, Wierts R, Joris PJ, Schrauwen-Hinderling VB, Phielix E, Bengtsson T, Schrauwen P, Hoeks J. Prolonged beta2-agonist treatment enhances muscle-specific glucose uptake in individuals with overweight and obesity: a randomized placebo-controlled trial. Nat Commun. 2026 Apr 21;17(1):5483. doi: 10.1038/s41467-026-71897-9.
PubMed 42014715
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. 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 Obese Humans
- ClinicalTrials.gov ID
- NCT04921306
- Acronym / sponsor ID
- NL76746.068.21
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Eurostars
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 10 Jun 2021 (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 four weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in overweight/obese male and (postmenopausal) female volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| 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 28 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 28 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
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian;
- Male or (postmenopausal; defined as 1 year after the last cycle) female;
- Age between 40-70 years;
- BMI: 27-35 kg/m2;
Key exclusion criteria (26 listed)
- Not meeting all inclusion criteria
- Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)
- Respiratory diseases (including asthma, bronchitis and COPD);
- Unstable body weight (weight gain or loss > 3 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 28 days with a wash-out period of at least 6-8 weeks. | Drug | Clenbuterol hydrochloride |
| PlaceboDaily ingestion of placebo capsules for a total period of 28 days with a wash-out period of at least 6-8 weeks. | Drug | Placebo |
Primary outcome
insulin-stimulated fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle.
Time frame: 4 weeks
Comparison between prolonged (4 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated 18F-FDG uptake in quadriceps muscle as assessed using radio-active labelled tracer (18F-FDG) in positron emission tomogaphy magnetic resonance imaging (PET-MRI).
1 secondary outcome
insulin-stimulated 18F-FDG uptake in BAT
Time frame: 4 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 7 May 2024.
- Derived from this study: PubMed 42014715Van Lier PMG, van de Weijer T, Vanweert F, Brouwers K, Nijssen KMR, Schaart G, Moonen-Kornips E, van Beek SMM, Springer S, Wierts R, Joris PJ, Schrauwen-Hinderling VB, Phielix E, Bengtsson T, Schrauwen P, Hoeks J. Prolonged beta2-agonist treatment enhances muscle-specific glucose uptake in individuals with overweight and obesity: a randomized placebo-controlled trial. Nat Commun. 2026 Apr 21;17(1):5483. doi: 10.1038/s41467-026-71897-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 2 Diabetes, 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 4 inclusion and 26 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 7 May 2024. 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 fluorodeoxyglucose (18F-FDG) uptake in quadriceps muscle. (time frame: 4 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 NCT04921306, 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 7 May 2024.