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

Primary Purpose

Hyperthyroidism

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Propranolol
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperthyroidism focused on measuring Brown adipose tissue (BAT), Hyperthyroidism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel, Department of Endocrinology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Propranolol 80 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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 (ΔREEPropranolol).

Secondary Outcome Measures

Respiratory quotient (RQ) before and after administration of propranolol.
Difference in respiratory quotient (RQ) before and after administration of propranolol.
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.
Difference in REE from hyperthyroid to euthyroid state
indirect calorimetry to determine resting energy expenditure
Difference in REE hyperthyroid state to euthyroid state
indirect calorimetry to determine resting energy expenditure
Change in Body composition: percent body fat
dual xray absorption scan
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.

Full Information

First Posted
December 7, 2017
Last Updated
February 12, 2020
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03379181
Brief Title
Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
Acronym
HEAT
Official Title
Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism
Keywords
Brown adipose tissue (BAT), Hyperthyroidism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol 80 mg
Arm Type
Experimental
Arm Description
Patients receive a single dose of 80 mg propranolol p.o.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
beta blockade
Intervention Description
Patients receive a single dose of 80 mg propranolol p.o.
Primary Outcome Measure Information:
Title
acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism
Description
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).
Time Frame
90 minutes after propranolol application
Secondary Outcome Measure Information:
Title
Respiratory quotient (RQ) before and after administration of propranolol.
Description
Difference in respiratory quotient (RQ) before and after administration of propranolol.
Time Frame
90 minutes after propranolol application
Title
Difference in skin temperature
Description
Supraclavicular skin temperature in patients with hyperthyroidism after a single dose of 80 mg Propranolol compared to supraclavicular temperature before Propranolol.
Time Frame
90 minutes after propranolol application
Title
Difference in REE from hyperthyroid to euthyroid state
Description
indirect calorimetry to determine resting energy expenditure
Time Frame
after 3 to 4 months
Title
Difference in REE hyperthyroid state to euthyroid state
Description
indirect calorimetry to determine resting energy expenditure
Time Frame
after 6 to 7 months
Title
Change in Body composition: percent body fat
Description
dual xray absorption scan
Time Frame
after 3 to 4 months
Title
Cold induced thermogenesis (CIT) in patients with hyperthyroidism
Description
Cold induced thermogenesis: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus during hyperthyroidism as compared to euthyroidism.
Time Frame
after 3 to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias J Betz, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Department of Endocrinology
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34570185
Citation
Maushart CI, Senn JR, Loeliger RC, Siegenthaler J, Bur F, Fischer JGW, Betz MJ. Resting Energy Expenditure and Cold-induced Thermogenesis in Patients With Overt Hyperthyroidism. J Clin Endocrinol Metab. 2022 Jan 18;107(2):450-461. doi: 10.1210/clinem/dgab706.
Results Reference
derived

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Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy

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