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NCT Number: NCT07410637

Impact of Thyroid Hormones on Human Glucose and Energy Metabolism

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Insulin sensitivity

    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.

  2. Insulin secretion

    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.

Secondary outcomes

  1. Resting energy expenditure.

    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.

  2. Respiratory Quotient

    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.

  3. Lipid metabolism

    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.

  4. Hepatic steatosis

    Time frame: baseline

    Presence of hepatic steatosis assessed by liver ultrasound including elastography.

  5. Heart rate variability

    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.

  6. Eating behavior

    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.

Other outcomes

  1. Perceived quality of life

    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.

  2. Perceived chronic stress

    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.

  3. Perceived Stress in the last month

    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

  4. Somatization, anxiety and depression

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Heni, Prof

CONTACT

[email protected]

+4973150044505

Roza Sabia, MD

CONTACT

[email protected]

+4973150044719

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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