Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis

NCT05711199 | Completed Early Phase 1

• 1 other identifier: NEXT Study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of glyceroltrinitrate (Nitroderm® TTS) to activate and expand human BAT as compared to mild cold exposure.

Conditions

Brown Adipose Tissue

Keywords

energy expenditure; glyceroltrinitrate; cold exposure

Outcome Measures

Primary Outcomes (2)

• BAT SUVmean

  18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F-

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

• BAT SUVmax

  maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0)

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

Secondary Outcomes (6)

• BAT Volume

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

• BAT glycolytic volume

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

• Energy expenditure

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

• Cold induced thermogenesis

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

• Mixed meal test

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

Other Outcomes (1)

• Tissue biopsies of supraclavicular BAT and skeletal muscle musculus vastus lateralis

  After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively

Study Arms (2)

Treatment

EXPERIMENTAL

1. administration of glyceroltrinitrate (Nitroderm TTS) for 15 days. 2. measurement of energy expenditure before and after cold exposure 3. performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) 4. measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test.

Drug: Glyceroltrinitrat

Control

NO INTERVENTION

1. measurement of energy expenditure before and after cold exposure 2. performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) 3. measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test.

Interventions

Glyceroltrinitrat DRUG

transdermal patch

Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.5 to 25 kg/m2 or 30 to 35kg/m2
• Able to give informed consent as documented by signature
• Age 18 to 40 years

You may not qualify if:

• Contraindications to glyceroltrinitrate, e.g. known hypersensitivity or allergy
• Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin, PDE-5-inhibitors
• Clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
• Hypersensitivity to cold (e.g. Raynaud Syndrome)
• Orthostatic hypotension: systolic blood pressure decreases min. 20mmHg or diastolic blood pressure decreases min 10mmHg within 3-5min after standing up (Schellong Test at screening visit)
• History of orthostatic syncope or pre-syncope
• Blood pressure values below 100 mmHg systolic and 60 mmHg diastolic
• Allergy to local anesthetic
• Hypothyroidism without sufficient substitution
• Hyperthyroidism
• Claustrophobia
• Smoker / habitual tobacco use
• Habitual excessive alcohol use
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Matthias J Betz, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: March 1, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 30, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)