Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes
NCT ID: NCT04298684
Last Updated: 2020-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2021-01-01
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Metformin
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.
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
In arm 2, sitagliptin will be prescribed at 100mg / day. A classic follow-up will be done every 3 months.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Ioduria \<100ug /L
* Thyroid autoimmunity: positive anti-peroxidase, thyroglobulin or anti-TSH receptors antibodies
* Levothyroxine treatment
* History of cervical radiotherapy or thyroid surgery
* Type 1 diabetes
* Insulin deficiency
* History of hypersensitivity to one of the active substances
* History of pancreatitis
* Obesity linked to endocrine disease
* Presence of severe complications of T2DM (ischemic heart disease, heart failure with reduced left ventricular ejection fraction, severe lower extremity arteritis, gangrene, retinopathy, end-stage renal failure, cerebrovascular accident)
* HbA1c levels \> 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, iodized products etc. ...
* Acute conditions that may impair renal function such as: dehydration, severe infection, shock
* Respiratory failure
* Metabolic acidosis
18 Years
65 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de la Guadeloupe
OTHER
Responsible Party
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Principal Investigators
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Fritz-Line FLV VELAYOUDOM, MD
Role: STUDY_DIRECTOR
CHU de la Guadeloupe
Locations
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CHU Bordeaux
Bordeaux, , France
CHU Limoges
Limoges, , France
University Hospital Center of Guadeloupe
Pointe-à-Pitre, , Guadeloupe
CHU de la Réunion
Saint-Pierre, , Reunion
Countries
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Central Contacts
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Facility Contacts
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References
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Anil C, Akkurt A, Ayturk S, Kut A, Gursoy A. Impaired glucose metabolism is a risk factor for increased thyroid volume and nodule prevalence in a mild-to-moderate iodine deficient area. Metabolism. 2013 Jul;62(7):970-5. doi: 10.1016/j.metabol.2013.01.009. Epub 2013 Feb 5.
Ayturk S, Gursoy A, Kut A, Anil C, Nar A, Tutuncu NB. Metabolic syndrome and its components are associated with increased thyroid volume and nodule prevalence in a mild-to-moderate iodine-deficient area. Eur J Endocrinol. 2009 Oct;161(4):599-605. doi: 10.1530/EJE-09-0410. Epub 2009 Jul 24.
Barbesino G. Drugs affecting thyroid function. Thyroid. 2010 Jul;20(7):763-70. doi: 10.1089/thy.2010.1635.
Bonnet F, Scheen A. Understanding and overcoming metformin gastrointestinal intolerance. Diabetes Obes Metab. 2017 Apr;19(4):473-481. doi: 10.1111/dom.12854. Epub 2017 Feb 22.
Chen G, Xu S, Renko K, Derwahl M. Metformin inhibits growth of thyroid carcinoma cells, suppresses self-renewal of derived cancer stem cells, and potentiates the effect of chemotherapeutic agents. J Clin Endocrinol Metab. 2012 Apr;97(4):E510-20. doi: 10.1210/jc.2011-1754. Epub 2012 Jan 25.
Clemmons DR. Structural and functional analysis of insulin-like growth factors. Br Med Bull. 1989 Apr;45(2):465-80. doi: 10.1093/oxfordjournals.bmb.a072335.
American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.
Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956.
Hazel-Fernandez L, Xu Y, Moretz C, Meah Y, Baltz J, Lian J, Kimball E, Bouchard J. Historical cohort analysis of treatment patterns for patients with type 2 diabetes initiating metformin monotherapy. Curr Med Res Opin. 2015;31(9):1703-16. doi: 10.1185/03007995.2015.1067194. Epub 2015 Aug 27.
Junik R, Kozinski M, Debska-Kozinska K. Thyroid ultrasound in diabetic patients without overt thyroid disease. Acta Radiol. 2006 Sep;47(7):687-91. doi: 10.1080/02841850600806308.
Levy JC, Matthews DR, Hermans MP. Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 1998 Dec;21(12):2191-2. doi: 10.2337/diacare.21.12.2191. No abstract available.
Liu MZ, He HY, Luo JQ, He FZ, Chen ZR, Liu YP, Xiang DX, Zhou HH, Zhang W. Drug-induced hyperglycaemia and diabetes: pharmacogenomics perspectives. Arch Pharm Res. 2018 Jul;41(7):725-736. doi: 10.1007/s12272-018-1039-x. Epub 2018 Jun 1.
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
Menendez C, Baldelli R, Camina JP, Escudero B, Peino R, Dieguez C, Casanueva FF. TSH stimulates leptin secretion by a direct effect on adipocytes. J Endocrinol. 2003 Jan;176(1):7-12. doi: 10.1677/joe.0.1760007.
Meng X, Xu S, Chen G, Derwahl M, Liu C. Metformin and thyroid disease. J Endocrinol. 2017 Apr;233(1):R43-R51. doi: 10.1530/JOE-16-0450. Epub 2017 Feb 14.
Pladevall M, Williams LK, Potts LA, Divine G, Xi H, Lafata JE. Clinical outcomes and adherence to medications measured by claims data in patients with diabetes. Diabetes Care. 2004 Dec;27(12):2800-5. doi: 10.2337/diacare.27.12.2800.
Rezzonico JN, Rezzonico M, Pusiol E, Pitoia F, Niepomniszcze H. Increased prevalence of insulin resistance in patients with differentiated thyroid carcinoma. Metab Syndr Relat Disord. 2009 Aug;7(4):375-80. doi: 10.1089/met.2008.0062.
Rezzonico J, Rezzonico M, Pusiol E, Pitoia F, Niepomniszcze H. Introducing the thyroid gland as another victim of the insulin resistance syndrome. Thyroid. 2008 Apr;18(4):461-4. doi: 10.1089/thy.2007.0223.
Sui M, Yu Y, Zhang H, Di H, Liu C, Fan Y. Efficacy of Metformin for Benign Thyroid Nodules in Subjects With Insulin Resistance: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2018 Aug 28;9:494. doi: 10.3389/fendo.2018.00494. eCollection 2018.
Tang Y, Yan T, Wang G, Chen Y, Zhu Y, Jiang Z, Yang M, Li C, Li Z, Yu P, Wang S, Zhu N, Ren Q, Ni C. Correlation between Insulin Resistance and Thyroid Nodule in Type 2 Diabetes Mellitus. Int J Endocrinol. 2017;2017:1617458. doi: 10.1155/2017/1617458. Epub 2017 Oct 12.
Vella V, Sciacca L, Pandini G, Mineo R, Squatrito S, Vigneri R, Belfiore A. The IGF system in thyroid cancer: new concepts. Mol Pathol. 2001 Jun;54(3):121-4. doi: 10.1136/mp.54.3.121.
Wemeau JL, Sadoul JL, d'Herbomez M, Monpeyssen H, Tramalloni J, Leteurtre E, Borson-Chazot F, Caron P, Carnaille B, Leger J, Do Cao C, Klein M, Raingeard I, Desailloud R, Leenhardt L; French Society of Endocrinology. [Recommendations of the French Society of Endocrinology for the management of thyroid nodules]. Presse Med. 2011 Sep;40(9 Pt 1):793-826. No abstract available. French.
Yeo Y, Ma SH, Hwang Y, Horn-Ross PL, Hsing A, Lee KE, Park YJ, Park DJ, Yoo KY, Park SK. Diabetes mellitus and risk of thyroid cancer: a meta-analysis. PLoS One. 2014 Jun 13;9(6):e98135. doi: 10.1371/journal.pone.0098135. eCollection 2014.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2008 Jan;31 Suppl 1:S55-60. doi: 10.2337/dc08-S055. No abstract available.
Other Identifiers
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2019-000676-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PAP_RI1_2019/1
Identifier Type: -
Identifier Source: org_study_id
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