Authors
»
Derbyshire, Abi -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2015
INTERVENTION: Women with a BMI >40 who are seen by the Sleep Apnoea Service at Salford Royal Hospital will be asked if they wish to participate in the trial. They will complete a questionnaire, blood samples and biopsies of the lining of the womb taken before and after insertion of a Mirena IUS. CONDITION: Topic: Cancer, Metabolic and endocrine disorders; Subtopic: Gynaecological Cancer, Metabolic and Endocrine (all Subtopics); Disease: Uterus/Endometrium, Metabolic & Endocrine (not diabetes) ; Cancer PRIMARY OUTCOME: 1. Ki‐67 SECONDARY OUTCOME: 1. Histopathology; 2. Phospho‐H3; 3. Cleaved Caspase 3, cleaved PARP; 4. MAPK signalling molecules and their phosphorylated isoforms; 5. P13K‐AKT‐mTOR signalling molecules and their phosphorylated isoforms; 6. PTEN and AMPK, P53; 7. Strathmin, cyclin A, c‐myc; 8. Oestrogen, progesterone, LH, FSH, insulin, adiponectin and leptin receptors; 9. IGF‐1IR, IGF2, EIG121, RALDH2, SFRP‐1, SFRP‐4, Survivin; 10. Endocrine markers including but not limited to:; 11. Fasting serum glucose & insulin, HbA1c, IGFBP‐1 and C‐peptide levels; 12. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP; 13. Leptin, adiponectin; 14. Changes in menstrual function, physical and mental wellbeing INCLUSION CRITERIA: 1. Women seen in sleep apnoea clinic at Salford Royal Hospital 2. BMI>40 3. Informed consent 4. Aged 18 years or over 5. Not actively trying to lose weight 6. Normal up to date smear 7. Normal endometrial sampling at screening
Epistemonikos ID: be2e387a0f1dda5158de4f47a83eb93482e9f4ae
First added on: Aug 23, 2024