Ulm University Hospital
Ulm, Baden-Wurttemberg, 89081, Germany
Location status: Recruiting
Location contact
Roza Sabia, MD
CONTACT
Sabrina Wangler
CONTACT
NCT Number: NCT07410637
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.
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Request InfoAll sexes
Interventional
Not applicable
Ulm, Baden-Wurttemberg, 89081, Germany
Location status: Recruiting
Roza Sabia, MD
CONTACT
Sabrina Wangler
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 2 weeks, 3 months
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.
Time frame: Baseline, 2 weeks, 3 months
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.
Time frame: Baseline, 2 weeks, 3 months
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.
Time frame: Baseline, 2 weeks, 3 months
Effect of changes in thyroid hormone levels on respiratory quotient assessed by indirect calometry before and during the 75 g oral glucose tolerance test.
Time frame: Baseline, 2 weeks, 3 months
Effect of changes in thyroid hormone levels on lipid metabolism assessed from lipid measurements during the 75 g oral glucose tolerance test.
Time frame: baseline
Presence of hepatic steatosis assessed by liver ultrasound including elastography.
Time frame: Baseline, 2 weeks, 3 months
Effect of changes in thyroid hormone levels on heart rate variability assessed by electrocardiography during the 75 g oral glucose tolerance test.
Time frame: Baseline, 3 months
Effect of changes in thyroid hormone levels on eating behavior assessed by dietary protocols before the start of treatment and 3 months later.
Time frame: either at baseline, two weeks or three months
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.
Time frame: cross-sectional either at baseline, two weeks or three 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.
Time frame: cross-sectional either at baseline, two weeks or three months
Perceived stress in the last months assessed through Perceived Stress Scale (PSS) on a 0-40 scale where higher values indicate higher perceived stress
Time frame: cross-sectional either at baseline, two weeks or three months
Somatization, anxiety and depression assessed through the Brief symptom inventory (BSI-18) on a 0-77 scale where higher values indicate higher distress
Contact information is provided by the study sponsor or research team.
Martin Heni, Prof
CONTACT
Roza Sabia, MD
CONTACT
University of Ulm
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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