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Recruiting NCT07410637

Impact of Thyroid Hormones on Human Glucose and Energy Metabolism

No phase Interventional Graves Disease Thyroid Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Glucose Tolerance Test.
Who it may be relevant to
Registry conditions: Graves Disease, Thyroid Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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.

Interventions

  • Other Oral Glucose Tolerance Test
    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.

Primary outcome measures

  • Insulin sensitivity [Time frame: Baseline, 2 weeks, 3 months]
  • Insulin secretion [Time frame: Baseline, 2 weeks, 3 months]
Secondary outcome measures (6)
  • Resting energy expenditure. [Time frame: Baseline, 2 weeks, 3 months]
  • Respiratory Quotient [Time frame: Baseline, 2 weeks, 3 months]
  • Lipid metabolism [Time frame: Baseline, 2 weeks, 3 months]
  • Hepatic steatosis [Time frame: baseline]
  • Heart rate variability [Time frame: Baseline, 2 weeks, 3 months]
  • Eating behavior [Time frame: Baseline, 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Germany · 1 center
  • Ulm University Hospital — Ulm

Identifiers

NCT: NCT07410637 · 173/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗