Impact of Thyroid Hormones on Human Glucose and Energy Metabolism

University of Ulm

Status: Enrolling

Conditions: Thyroid Cancer; Graves Disease

Treatments: Other: Oral Glucose Tolerance Test

Study type: Interventional

Funder types: Other

Identifiers

NCT07410637

173/23

Details and patient eligibility

About

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.

Full description

This research project aims to clarify the role of changes in thyroid hormone levels in glucose and liver metabolism.

Thyroid hormones regulate endogenous glucose production, insulin sensitivity, lipid metabolism, and lipid storage in the liver. They also appear to enhance insulin sensitivity in other tissues. Furthermore, thyroid hormones stimulate lipolysis and reduce total and LDL-cholesterol levels. The impact of thyroid hormones on insulin secretion is controversial, with some trials demonstrating increased secretion and others showing decreased secretion. Most of this evidence is derived from animal trials, and prospective human trials are lacking.

Clinical scenarios where thyroid hormone levels are altered through therapeutic interventions will be used. In patients with Graves' disease, hyperthyroidism is pharmacologically reduced, whereas in patients with thyroid carcinoma, hyperthyroidism is pharmacologically induced. Before the start of treatment, two weeks and three months after start of treatment oral glucose tolerance tests will be performed for metabolic characterization. Using this approach, differences in glycemic, insulin sensitivity, insulin secretion, lipids, resting energy expenditure, respiratory quotient, hepatic steatosis, eating and exercise behavior will be assessed.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Phenotyping Cohort

Other group

Description:

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

Treatment:

Other: Oral Glucose Tolerance Test