Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
- Registration Number
- NCT03379181
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
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Contraindications to propranolol: hypersensitivity or allergy
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Therapy with a beta blocker for reasons other than hyperthyroidism (e.g. cardiac arrhythmia or heart failure)
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Treatment with amiodarone
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Women who are pregnant or breast feeding,
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Intention to become pregnant during the course of the study,
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History of asthma or chronic obstructive pulmonary disease
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Occlusive peripheral artery disease; Raynaud's syndrome.
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Other clinically significant concomitant disease states:
- Known renal failure (GFR < 50 ml/min)
- Known hepatic dysfunction
- known heart failure or unstable angina pectoris
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Known or suspected non-compliance, drug or alcohol abuse,
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Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
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Participation in another study with investigational drug within the 30 days preceding and during the present study,
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Previous enrolment into the current study,
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Enrolment of the investigator, his/her family members, employees and other dependent persons.
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ECG-criteria
- Resting heart rate below 60 bpm
- Complete left bundle branch block
- Atrioventricular block (AV-block) grade 2 or 3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Propranolol 80 mg Propranolol Patients receive a single dose of 80 mg propranolol p.o.
- Primary Outcome Measures
Name Time Method acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism 90 minutes after propranolol application 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).
- Secondary Outcome Measures
Name Time Method Change in Body composition: percent body fat after 3 to 4 months dual xray absorption scan
Cold induced thermogenesis (CIT) in patients with hyperthyroidism after 3 to 4 months Cold induced thermogenesis: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus during hyperthyroidism as compared to euthyroidism.
Difference in REE hyperthyroid state to euthyroid state after 6 to 7 months indirect calorimetry to determine resting energy expenditure
Respiratory quotient (RQ) before and after administration of propranolol. 90 minutes after propranolol application Difference in respiratory quotient (RQ) before and after administration of propranolol.
Difference in REE from hyperthyroid to euthyroid state after 3 to 4 months indirect calorimetry to determine resting energy expenditure
Difference in skin temperature 90 minutes after propranolol application Supraclavicular skin temperature in patients with hyperthyroidism after a single dose of 80 mg Propranolol compared to supraclavicular temperature before Propranolol.
Trial Locations
- Locations (1)
University Hospital Basel, Department of Endocrinology
🇨🇭Basel, BS, Switzerland