newly diagnosed subjects with uncomplicated T2DM and begnin TN of at least 2 cm of size, after pregnancy exclusion if women
Conditions
Interventions
Product Name: METFORMIN
Pharmaceutical Form: Coated tablet
Product Name: sitagliptin
Pharmaceutical Form: Coated tablet
Sponsors
University Center Hospital of Guadeloupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with T2DM aged 18 to 65 years; - Uncomplicated T2DM, evolving for less than 3 years; - Patients with HbA1c levels between 7 and 8% (after the run-in period) - Patients with at least one TN = 2 cm non-cystic, whose benignity will be confirmed by a fine-needle aspiration cytology performed twice regardless of ultrasound TIRADS score; - Naive subjects of any treatment: never received an anti-diabetic treatment OR received an anti-diabetic treatment of less than 30 days since diagnosis OR did not receive an anti-diabetic treatment during the 30 days before screening; - Patients with a creatinine clearance > 60 ml/min; - Informed and written consent signed by the patient and the investigator; - Affiliation to the national social health system or equivalent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, curatorship or safeguard of justice - Pregnant or breastfeeding woman - Woman of childbearing potential without effective contraception (estroprogestative, presentative, intrauterine device) - Suspect thyroid nodules in ultrasound (TIRADS 4 to 5) with confirmation after a fine-needle aspiration cytology; - Thyroid function abnormalities or a history of thyroid disease; - Thyroid nodules whose size or symptoms (compressive signs) require surgery - Urinary iodures 8% after the run-in period - Liver diseases (liver failure, cirrhosis, viral hepatitis B or C) - Acute alcoholic intoxication, chronic alcoholism - Psychiatric diseases (depression, schizophrenia) - Neurological diseases (epilepsy, demyelinating diseases, etc.) - Treatment influencing the morphology or thyroid function: corticosteroids, lithium etc. ... - Acute conditions that may impair renal function such as: dehydration, severe infection…
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare the efficacy of metformin versus sitagliptin on the evolution of benign thyroid nodules greater than 2 cm in subjects with newly diagnosed type 2 diabetes mellitus.;Secondary Objective: - 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 TSH, T4 and T3 levels - Percentage of IGF-1 and adiponectin receptor expression in thyroid tissues after TN surgery ;Primary end point(s): Percentage of patients in each group who had a decrease of at least 20% in one or more nodules larger than 2 cm to 2 years;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - percentage of thyroid surgery observed in each group at 2 years. During follow-up, surgery will be indicated in the presence of an NT having increased in size and associated with either 1 / symptoms of local compression, or 2 / a suspicion of malignancy at the needle aspiration performed in the presence of ultrasound criteria TIRADS 4 or 5; - The number of new nodules (= 10mm) in ultrasound at 2 years; - The percentage of metabolic syndrome before and after treatment; - HOMA index variations and adipokine concentrations after 2 years; - Changes in plasma concentrations of TSH, T4, T3 after 2 years; - The percentage of expression of IGF-1 and adiponectin receptors in NT operated in group 1 compared to group 2. ;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
France
Contacts
Public ContactPETAPERMAL Melanie
University Center Hospital of Guadeloupe
Outcome results
None listed