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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04298684
Other study ID # PAP_RI1_2019/1
Secondary ID 2019-000676-42
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2021
Est. completion date July 1, 2024

Study information

Verified date September 2020
Source Centre Hospitalier Universitaire de Pointe-a-Pitre
Contact Valerie VS HAMONY SOTER
Phone +590590934686
Email valerie.soter@chu-guadeloupe.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 2-years prospective, randomized and multicentric study will be performed to assess the efficacy of metformin compared to sitagliptin on benign thyroid nodules size ≥ 2 cm, in newly diagnosed patients with type 2 diabetes.


Description:

Previous studies reported that prevalence of thyroid nodules (TN) is increased in patients with insulin resistance (IR) and type 2 diabetes mellitus (T2DM). However, there are no guidelines for the management of TN in this target population. In 2013, the French National Health Insurance reported that thyroid surgery procedures for benign nodules have increased unjustifiably. The impact of such surgery on the patients could be serious, with psychological repercussions and risks of surgical complications and the need of a substitutive lifetime hormonal treatment. The investigators hypothesize that metformin may reduce the need of TN surgery by decreasing benign TN size through a reduction of IR profile. A 2-years multicentric prospective study will be conducted to compare efficacy of metformin versus sitagliptin on benign thyroid nodules size in patients with initial benign thyroid nodules ≥ 2 cm. The percentage of thyroid surgery avoided, IR profile measured by Homeostasis Model Assessment of Insulin Resistance-Index (HOMA-IR-index) and adipokines concentrations will be also collected at inclusion ad at 2 years. The Primary outcome will be the percentage of patients in each group who had at least a 20% decrease in one or more nodules of more than 2 cm at 2 years. Several secondary outcomes will be registered: percentage of thyroid surgery observed in each group at 2 years, number of new TN (≥ 10mm) after 2 years of follow-up , percentage of metabolic syndrome before and after treatment, proportion of subjects with improvement of the HOMA-IR index and adipokine concentrations, plasmatic thyroid-stimulating hormone (TSH), T4 and T3 levels evolution, percentage of insulin like growth factor-1 (IGF-1) and adiponectin receptor expression in thyroid tissues after TN surgery.


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Study Design


Intervention

Drug:
METFORMIN
After inclusion, a central randomization will allow subjects to benefit from either metformin (group 1) or sitagliptin (group 2). A follow-up schedule will be given to the included patient for future visits. thyroid ultrasonography to analyze the TN evolution in the 2 groups. In arm 1, the subjects will receive metformin at the initial dose of 500mg x 2 / day, which will be increased weekly to 500mgx3 / day and then 1gx2 / day in order to obtain the minimum effective dose on glycemic control. In case of intolerance, the tolerated and effective dose will be taken back provided an effective glycemic control. A classic follow-up will be done every 3 months. Thyroid US and measure of HOMA-IR index will be done every 6 months for 2 years. If the goal of HbA1c will not achieved, a treatment with glicazide will be introduced.
Sitagliptin
After inclusion, a central randomization will allow subjects to benefit from either metformin (group 1) or sitagliptin (group 2). A follow-up schedule will be given to the included patient for future visits. thyroid ultrasonography to analyze the TN evolution in the 2 groups. In arm 2, sitagliptin will be prescribed at 100mg / day. A classic follow-up will be done every 3 months. Thyroid US and measure of HOMA-IR index will be done every 6 months for 2 years. If the goal of HbA1c will not achieved, a treatment with glicazide will be introduced.

Locations

Country Name City State
France CHU Bordeaux Bordeaux
France CHU Limoges Limoges
Guadeloupe University Hospital Center of Guadeloupe Pointe-à-Pitre
Réunion CHU de la Réunion Saint-Pierre

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Pointe-a-Pitre

Countries where clinical trial is conducted

France,  Guadeloupe,  Réunion, 

References & Publications (24)

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Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients in each group who had at least a 20% decrease in one or more nodules of more than 2 cm at 2 years. Size : The reduction of TN will be evaluated by thyroid ultrasonography. The operator will be the same throughout the follow-up and in each center, with an evaluation every 6 months. A measurement and precise analysis of the TN will be performed. If a TIRADS 4 or 5 classification is described , a new fine-needle aspiration cytology will be performed. A final thyroid ultrasonography evaluation will be performed at 2 years in order to allow the comparison of TN sizes from the pre-inclusion period to the final period. 24 months
Secondary Percentage of thyroid surgery observed in each group at 2 years. Record the number of thyroid surgeries performed after inclusion for 2 years 24 months after treatment initiation
Secondary Number of new TN (= 10mm) after 2 years of follow-up Detection of new TN (= 10mm) by thyroid ultrasonography. The operator will be the same throughout the follow-up and in each center Baseline and 24 months after treatment initiation
Secondary Change between percentage of metabolic syndrome before and after treatment according to the NCEP ATP III definition Central or abdominal obesity (measured by waist circumference):
Men - greater than 40 inches (102 cm)
Women - greater than 35 inches (88cm) Triglycerides plasmatic levels greater than or equal to 150 mg/dL (1.7 mmol/L)
HDL cholesterol :
Men - Less than 40 mg/dL (1.03 mmol/L)
Women - Less than 50 mg/dL (1.29 mmol/L) Blood pressure greater than or equal to 130/85 mm Hg Fasting glucose greater than or equal to 110 mg/dL (6.1 mmol/L)
Baseline, every 6 months after treatment initiation until 24 months
Secondary Proportion of subjects with improvement of the HOMA-IR index The HOMA index will be measured after calculation the ratio between the [fasting plasma insulin (Mu / L) X Fasting plasma glucose (mmol / l)] / 22.5 Baseline, every 6 months after treatment initiation until 24 months
Secondary Proportion of subjects with improvement of adipokine concentrations Among the adipokines, we will measure the plasmatic Leptin, Adiponectin and Vifastin levels Baseline and 24 months after treatment initiation
Secondary Plasmatic thyroid hormon levels these dosages will allow us to evaluate the changes in the functioning of the nodular thyroid gland during follow-up under either treatment Baseline, every 6 months after treatment initiation until 24 months
Secondary Percentage of IGF-1 receptor expression in thyroid tissues after TN surgery The analysis of the tissue expression of IGF1 receptors will be performed on thyroid samples after surgery if performed. One sample will be frozen and another will be included in paraffin for further analysis. IGF1 receptors are involved in the insulin and glucose metabolism signaling pathways. Analysis of their expression could help us to understand the possible links between insulin resistance and thyroid nodule. through study completion, an average of 1 year
Secondary Percentage of adiponectin receptor expression in thyroid tissues after TN surgery The analysis of the tissue expression of adiponectin receptor will be performed on thyroid samples after surgery if performed. One sample will be frozen and another will be included in paraffin for further analysis. Adiponectin receptor are involved in the insulin and glucose metabolism signaling pathways. Analysis of their expression could help us to understand the possible links between insulin resistance and thyroid nodule. through study completion, an average of 1 year
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