Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Neoplasms

Hypothyroidism

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Micronutrients

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Hormones

Iodine

Cadexomer iodine

The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy

Suk Kyeong Kim, MD, PhD

Jee Hyun An, MD, PhD

Jee Hyun An

Suk Kyoung Kim, MD, PhD

Ki Ho Song, MD, PhD

Dong Lim Kim, MD, PhD

1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.
2. Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.
3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.

1. Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)
2. Measurements

   1. Measurement of metabolic and cardiovascular parameters

      * glucose profiles : HbA1c, fasting glucose level
      * lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride
      * adipocytokines : retinol binding protein(RBP)
      * 4, leptin, resistin, adiponectin
      * markers of endothelial and cardiac function : high-sensitivity C-reactive protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)
      * bone turnover markers : CTX, bone ALP
   2. Scoring of symptoms and signs of hypothyroidism (Zulewski score)

      * symptoms
      * physical signs

Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer

Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer

* glucose profiles : HbA1c, fasting glucose level
* lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride
* adipocytokines : retinol binding protein(RBP)4, leptin, resistin, adiponectin
* markers of endothelial and cardiac function : high-sensitivity C-reactive - protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)

* bone formation marker: bone ALP
* bone resorption marker: CTX

Konkuk University Medical Center

Associate professor

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Musculoskeletal Diseases

Blood and Lymph Conditions

Rare Diseases

Lung Neoplasms

Adenocarcinoma

Neoplasm Metastasis

Adenocarcinoma of Lung

Bone Neoplasms

Bone Marrow Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Lung Adenocarcinoma

Patients entering the group have a suspected first bone metastasis of adenocarcinoma lung cancer and should undergo bone biopsy to histologically prove the diagnosis.

The vast majority of bone biopsy are performed under CT-scan. In some rare cases, the histology will be performed during surgery (either biopsy of the bone metastasis or surgical piece when treating a fracture).

Bone metastases biopsy

Cyrille Confavreux, MD, PhD

Nadège Trehet-Mendel

Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival.

Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers.

Survival analyses will be performed using a proportional hazard regression model.

Urine Serum and plasma Bone biopsy Whole blood

Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)

Whole body densitometry is performed at baseline

Molecular characterization of the bone metastases by PCR (EGFR, KRAS, BRAF) and FISH (ALK)

Hospices Civils de Lyon

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Hypoglycemic Agents

Reproductive Control Agents

Antineoplastic Agents

Insulin

Insulin, Globin Zinc

Metformin

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Combined

Cyproterone Acetate

Cyproterone

Estrogens

Hormone Antagonists

Contraceptive Agents, Female

Androgens

Androgen Antagonists

Contraceptive Agents, Male

Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.

Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.

Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

Metformin 1500mgs per day

Sujata Kar, MD

Sujata Kar, M.D

Suneeta Panigrahi, B.A

Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E\&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India.

Intervention:

Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar \& 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)

Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)

OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women

To compare improvement in Menstrual cycle. Women will be required to maintain a menstrual calendar for the duration of the study and asked to fill a questionnaire before and after study duration.The questionnaire will cover menstrual cycle dates, duration and amount. Interpreting the answered will help in assessing improvement in menstrual pattern.

FG scores before and after treatment will be compared between the two arms. Modified Ferriman and Gallwey visual score will be used by a nurse to assess before and after the study period.

Acne scores before and after treatment will be compared between the two arms. Visual assessment of acne using "mild/moderate/severe " grades will be assessed before and after study by a physician.

Weight loss will be compared between the two arms following 6 months of treatment

Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.

Reduction in insulin levels following treatment will be compared between the two arms

Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment

75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer	NCT01744769	Hypothyroidism		18 Years - 80 Years	Konkuk University Medical Center
Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)	NCT02810262	Bone Metastases Lung Cancer	Bone metastases...	18 Years -	Hospices Civils de Lyon
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women	NCT02744131	Polycystic Ovar...	Oral contracept... Metformin 1500m...	16 Years - 40 Years	Kar Clinic & Hospital Pvt. Ltd.
Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)	NCT02810262	Bone Metastases Lung Cancer	Bone metastases...	18 Years -	Hospices Civils de Lyon
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer	NCT01744769	Hypothyroidism		18 Years - 80 Years	Konkuk University Medical Center
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer	NCT01744769	Hypothyroidism		18 Years - 80 Years	Konkuk University Medical Center

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