Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy

Hyperthyroidism Clinical Trial

— HEAT  

Official title:

Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379181
• Other study ID #: EKNZ 2017-02044
• Status: Completed
• Phase: Phase 4
• Start date: July 18, 2017
• Est. completion date: February 12, 2020

Study information

• Verified date: February 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperthyroidism

Intervention

Drug:
• Propranolol
Patients receive a single dose of 80 mg propranolol p.o.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Endocrinology	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?REEPropranolol).	90 minutes after propranolol application
Secondary	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
Secondary	Difference in skin temperature	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
Secondary	Difference in REE from hyperthyroid to euthyroid state	indirect calorimetry to determine resting energy expenditure	after 3 to 4 months
Secondary	Difference in REE hyperthyroid state to euthyroid state	indirect calorimetry to determine resting energy expenditure	after 6 to 7 months
Secondary	Change in Body composition: percent body fat	dual xray absorption scan	after 3 to 4 months
Secondary	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