Skip to main content
OpenTrials
Completed

NCT Number: NCT03379181

Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

Patients receive a single dose of 80 mg propranolol p.o.

Other names: beta blockade

Primary outcomes

  1. acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism

    Time frame: 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 outcomes

  1. Respiratory quotient (RQ) before and after administration of propranolol.

    Time frame: 90 minutes after propranolol application

    Difference in respiratory quotient (RQ) before and after administration of propranolol.

  2. Difference in skin temperature

    Time frame: 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.

  3. Difference in REE from hyperthyroid to euthyroid state

    Time frame: after 3 to 4 months

    indirect calorimetry to determine resting energy expenditure

  4. Difference in REE hyperthyroid state to euthyroid state

    Time frame: after 6 to 7 months

    indirect calorimetry to determine resting energy expenditure

  5. Change in Body composition: percent body fat

    Time frame: after 3 to 4 months

    dual xray absorption scan

  6. Cold induced thermogenesis (CIT) in patients with hyperthyroidism

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: HEAT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2017
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.