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HEAT: Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03379181
Collaborator
(none)
19
Enrollment
1
Location
1
Arm
30.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
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 :
Jul 18, 2017
Actual Primary Completion Date :
Feb 12, 2020
Actual Study Completion Date :
Feb 12, 2020

Arms and Interventions

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 Names:
  • beta blockade

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. Difference in REE from hyperthyroid to euthyroid state [after 3 to 4 months]

      indirect calorimetry to determine resting energy expenditure

    4. Difference in REE hyperthyroid state to euthyroid state [after 6 to 7 months]

      indirect calorimetry to determine resting energy expenditure

    5. Change in Body composition: percent body fat [after 3 to 4 months]

      dual xray absorption scan

    6. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel, Department of Endocrinology Basel BS Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Matthias J Betz, MD, University Hospital, Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT03379181
    Other Study ID Numbers:
    • EKNZ 2017-02044
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Hyperthyroidism
    Propranolol

    Study Results

    No Results Posted as of Feb 13, 2020