Clinical trial NCT03379181: Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
Official title: Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperthyroidism
Keywords: Brown adipose tissue (BAT)
Hyperthyroidism
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Age 18 to 70 years
* Hyperthyroidism: Thyroid-stimulating Hormone (TSH) below 0.2 mU and free T4 at or above 25 pmol/L or free T3 at or above 8 pmol/L.

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 renal failure (GFR \< 50 ml/min)
  * Known hepatic dysfunction
  * known heart failure or unstable angina pectoris
* 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

  * Resting heart rate below 60 bpm
  * Complete left bundle branch block
  * Atrioventricular block (AV-block) grade 2 or 3

Primary outcomes:
measure: acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism
timeFrame: 90 minutes after propranolol application
Secondary outcomes:
measure: Respiratory quotient (RQ) before and after administration of propranolol.
timeFrame: 90 minutes after propranolol application
measure: Difference in skin temperature
timeFrame: 90 minutes after propranolol application
measure: Difference in REE from hyperthyroid to euthyroid state
timeFrame: after 3 to 4 months
measure: Difference in REE hyperthyroid state to euthyroid state
timeFrame: after 6 to 7 months
measure: Change in Body composition: percent body fat
timeFrame: after 3 to 4 months
measure: Cold induced thermogenesis (CIT) in patients with hyperthyroidism
timeFrame: after 3 to 4 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Endocrinology
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias J Betz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.