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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenotyping Cohort | Other | Patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resting energy expenditure. | Effect of changes in thyroid hormone levels on resting energy expenditure assessed by indirect calometry before and during the 75 g oral glucose tolerance test. | Baseline, 2 weeks, 3 months |
| Respiratory Quotient |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived quality of life | Quality of life assessed by the World Health Organization Quality of Life- Brief (BREF) Questionnaire on a 0-100 scale where higher values indicate better quality of life. | either at baseline, two weeks or three months |
| Perceived chronic stress |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Heni, Prof | Contact | +4973150044505 | martin.heni@uniklinik-ulm.de | |
| Roza Sabia, MD | Contact | +4973150044719 | roza.sabia@uniklinik-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Martin Heni | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulm University Hospital | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D013964 | Thyroid Neoplasms |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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.
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|
Effect of changes in thyroid hormone levels on respiratory quotient assessed by indirect calometry before and during the 75 g oral glucose tolerance test.
| Baseline, 2 weeks, 3 months |
| Lipid metabolism | Effect of changes in thyroid hormone levels on lipid metabolism assessed from lipid measurements during the 75 g oral glucose tolerance test. | Baseline, 2 weeks, 3 months |
| Hepatic steatosis | Presence of hepatic steatosis assessed by liver ultrasound including elastography. | baseline |
| Heart rate variability | Effect of changes in thyroid hormone levels on heart rate variability assessed by electrocardiography during the 75 g oral glucose tolerance test. | Baseline, 2 weeks, 3 months |
| Eating behavior | Effect of changes in thyroid hormone levels on eating behavior assessed by dietary protocols before the start of treatment and 3 months later. | Baseline, 3 months |
Perceived chronic stress in the last three months assessed through the trier inventory for chronic stress (TICS-9) on a 0-45 scale on which higher values indicate higher chronic stress. |
| cross-sectional either at baseline, two weeks or three months |
| Perceived Stress in the last month | Perceived stress in the last months assessed through Perceived Stress Scale (PSS) on a 0-40 scale where higher values indicate higher perceived stress | cross-sectional either at baseline, two weeks or three months |
| Somatization, anxiety and depression | Somatization, anxiety and depression assessed through the Brief symptom inventory (BSI-18) on a 0-77 scale where higher values indicate higher distress | cross-sectional either at baseline, two weeks or three months |
| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |