Impact of Thyroid Hormones on Human Glucose and Energy Metabolism

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Insulin sensitivity [Срок оценки: Baseline, 2 weeks, 3 months]
• Insulin secretion [Срок оценки: Baseline, 2 weeks, 3 months]

Вторичные конечные точки (6)

• Resting energy expenditure. [Срок оценки: Baseline, 2 weeks, 3 months]
• Respiratory Quotient [Срок оценки: Baseline, 2 weeks, 3 months]
• Lipid metabolism [Срок оценки: Baseline, 2 weeks, 3 months]
• Hepatic steatosis [Срок оценки: baseline]
• Heart rate variability [Срок оценки: Baseline, 2 weeks, 3 months]
• Eating behavior [Срок оценки: Baseline, 3 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• Ulm University Hospital — Ulm

Идентификаторы

NCT: NCT07410637 · 173/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗