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The overall objective of the HEAT study is to determine the acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism and to evaluate the consequences of the change of hyper- to euthyroidism on metabolism during the course of treatment, especially with regard to the reaction to cold ambient temperatures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol 80 mg | Experimental | Patients receive a single dose of 80 mg propranolol p.o. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | Patients receive a single dose of 80 mg propranolol p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism | difference in resting energy expenditure (REE) measured single 90 minutes after an oral dose of 80 mg of propranolol compared to resting energy expenditure measured during the thirty minutes prior to administration of propranolol (ΔREEPropranolol). | 90 minutes after propranolol application |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory quotient (RQ) before and after administration of propranolol. | Difference in respiratory quotient (RQ) before and after administration of propranolol. | 90 minutes after propranolol application |
| Difference in skin temperature |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to propranolol: hypersensitivity or allergy
Therapy with a beta blocker for reasons other than hyperthyroidism (e.g. cardiac arrhythmia or heart failure)
Treatment with amiodarone
Women who are pregnant or breast feeding,
Intention to become pregnant during the course of the study,
History of asthma or chronic obstructive pulmonary disease
Occlusive peripheral artery disease; Raynaud's syndrome.
Other clinically significant concomitant disease states:
Known or suspected non-compliance, drug or alcohol abuse,
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
Participation in another study with investigational drug within the 30 days preceding and during the present study,
Previous enrolment into the current study,
Enrolment of the investigator, his/her family members, employees and other dependent persons.
ECG-criteria
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| Name | Affiliation | Role |
|---|---|---|
| Matthias J Betz, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Department of Endocrinology | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36743920 | Derived | Senn JR, Loliger RC, Fischer JGW, Bur F, Maushart CI, Betz MJ. Acute effect of propranolol on resting energy expenditure in hyperthyroid patients. Front Endocrinol (Lausanne). 2023 Jan 19;13:1026998. doi: 10.3389/fendo.2022.1026998. eCollection 2022. | |
| 34570185 | Derived | Maushart CI, Senn JR, Loeliger RC, Siegenthaler J, Bur F, Fischer JGW, Betz MJ. Resting Energy Expenditure and Cold-induced Thermogenesis in Patients With Overt Hyperthyroidism. J Clin Endocrinol Metab. 2022 Jan 18;107(2):450-461. doi: 10.1210/clinem/dgab706. |
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| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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Supraclavicular skin temperature in patients with hyperthyroidism after a single dose of 80 mg Propranolol compared to supraclavicular temperature before Propranolol.
| 90 minutes after propranolol application |
| Difference in REE from hyperthyroid to euthyroid state | indirect calorimetry to determine resting energy expenditure | after 3 to 4 months |
| Difference in REE hyperthyroid state to euthyroid state | indirect calorimetry to determine resting energy expenditure | after 6 to 7 months |
| Change in Body composition: percent body fat | dual xray absorption scan | after 3 to 4 months |
| Cold induced thermogenesis (CIT) in patients with hyperthyroidism | Cold induced thermogenesis: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus during hyperthyroidism as compared to euthyroidism. | after 3 to 4 months |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |