Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT06647602
Brief Summary:
This study will be a multicentre prospective cohort study on TH-substitution with liothyronine (L-T3) and levothyroxine (L-T4) in DTC patients after TH-withdrawal. The first cohort is patients treated in the University Medical Centre Groningen (UMCG) with L-T3 according to standard local protocol. The second cohort is patients treated in the Radboud University Medical Centre (Radboud UMC) with L-T4, also according to standard local protocol. We will compare effects of L-T3 or L-T4 on TSH, Thyroglobulin (Tg), quality of life (QoL), weight and cardiovascular parameters.
Detailed Description:
While treatment with L-T4 after TH-withdrawal is widely used in DTC patients to suppress TSH and improve hypothyroid symptoms, the value of L-T3 has not been evaluated in this context. Lifelong monotherapy with L-T3 should not be preferred over L-T4 yet, short-term use of L-T3 to initiate TH-supplementation can be safely implemented. We hypothesize that initial treatment with L-T3 can have a more rapid effect on TSH-levels and earlier relieve of hypothyroid symptoms resulting in a better QoL. To evaluate TH-supplementation with L-T3, we will conduct a prospective cohort study comparing the initiation of TH-supplementation after TH-withdrawal in two cohorts of DTC patients: patients treated in the University Medical Centre Groningen (UMCG) receiving L-T3 and patients treated in the Radboud University Medical Centre (Radboud UMC) receiving L-T4. We will compare potency to suppress TSH, effect on QoL and effects on thyroid- and cardiovascular parameters. Patients (18-75 years) diagnosed with high-risk DTC treated in the UMCG or Radboud UMC and receiving THST with L-T3 or L-T4 after TH-withdrawal will be eligible for inclusion. The primary objective is to compare the proportion of patients reaching target TSH-levels after two weeks of substitution with L-T3 or L-T4.
Secondary objectives are to compare the effects of L-T3 and L-T4 in the first 6 months of treatment on serum thyroid parameters TSH and Tg, quality of life, weight, and cardiovascular parameters
Study:
NCT06647602
Study Brief:
Protocol Section:
NCT06647602