Impact of Thyroid Hormones on Human Glucose and Energy Metabolism

NCT07410637 | Recruiting

• 1 other identifier: 173/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial to clarify the impact of changes in thyroid hormone levels on glucose and lipid metabolism. Patients will be included in whom thyroid hormone levels are intentionally changed by treatment. In patients with Graves' disease, thyroid hormone levels will be lowered using medication, while in patients with thyroid cancer, thyroid hormone levels will be raised using medication. Oral glucose tolerance tests will be performed before treatment and at two time points after treatment begins to assess metabolic effects.

Conditions

Graves Disease; Thyroid Cancer

Keywords

thyroid hormones; glucose metabolism; lipid metabolism; graves disease; thyroid cancer; hyperthyroidism

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity

  Effect of changes in thyroid hormone levels on whole-body insulin sensitivity, assessed from glucose and insulin measurements during the 75 g oral glucose tolerance test.

  Baseline, 2 weeks, 3 months

• Insulin secretion

  Effect of changes in thyroid hormone levels on insulin secretion, assessed from glucose and insulin/c-peptide measurements during the 75 g oral glucose tolerance test.

  Baseline, 2 weeks, 3 months

Secondary Outcomes (6)

• Resting energy expenditure.

  Baseline, 2 weeks, 3 months

• Respiratory Quotient

  Baseline, 2 weeks, 3 months

• Lipid metabolism

  Baseline, 2 weeks, 3 months

• Hepatic steatosis

  baseline

• Heart rate variability

  Baseline, 2 weeks, 3 months

Other Outcomes (4)

• Perceived quality of life

  either at baseline, two weeks or three months

• Perceived chronic stress

  cross-sectional either at baseline, two weeks or three months

• Perceived Stress in the last month

  cross-sectional either at baseline, two weeks or three months

Study Arms (1)

Phenotyping Cohort

OTHER

Patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment.

Other: Oral Glucose Tolerance Test

Interventions

Oral Glucose Tolerance Test OTHER

Participants will receive a 75 g oral glucose tolerance (3h) before the start of treatment, two weeks and three months after start of treatment. Body composition will measured by bioimpedance analysis. Before and during the oral glucose tolerance test, indirect calometry will assess metabolic flexibility.

Phenotyping Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with initial diagnosis of graves disease OR
• patients with initial diagnosis of thyroid carcinoma

You may not qualify if:

• contraindications for oral glucose tolerance test
• Diabetes mellitus
• Fasting glucose level ≥ 200 mg/dL
• Exogenous insulin administration with action at the time of the test
• Current disease with activation of stress hormones
• Post-aggressive metabolism
• Acute infectious disease

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Ulm University Hospital

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Graves Disease; Thyroid Neoplasms; Hyperthyroidism

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Martin Heni

  University of Ulm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Heni, Prof

CONTACT

+4973150044505; martin.heni@uniklinik-ulm.de

Roza Sabia, MD

CONTACT

+4973150044719; roza.sabia@uniklinik-ulm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Martin Heni

Model Details: This is a longitudinal mechanistic study evaluating the metabolic effects of changes in thyroid hormone levels on glucose and liver metabolism. Participants include patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment. The only study-specific intervention is repeated metabolic phenotyping using oral glucose tolerance tests (OGTTs) performed at baseline, two weeks, and three months after initiation of therapy. Thyroid hormone modulation occurs as part of routine clinical care and is not assigned by the study protocol.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 13, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)