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Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy (HEAT)

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ClinicalTrials.gov Identifier: NCT03379181
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperthyroidism Drug: Propranolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism

Arm Intervention/treatment
Experimental: Propranolol 80 mg
Patients receive a single dose of 80 mg propranolol p.o.
Drug: Propranolol
Patients receive a single dose of 80 mg propranolol p.o.
Other Name: beta blockade




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379181


Contacts
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Contact: Matthias J Betz, Dr. MD 0041 61 55 ext 65654 matthias.betz@usb.ch

Locations
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Switzerland
University Hospital Basel, Department of Endocrinology Recruiting
Basel, BS, Switzerland, 4031
Contact: Matthias J Betz, Dr. MD    0041 61 265 5078    matthias.betz@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias J Betz, MD University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03379181     History of Changes
Other Study ID Numbers: EKNZ 2017-02044
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
Brown adipose tissue (BAT)
Hyperthyroidism

Additional relevant MeSH terms:
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Propranolol
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents