ISRCTN76278694已完成未知
Investigation of the metabolic effects of duodenal resurfacing on insulin resistant women wIth polycystic ovarian syndrome
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female participants
- •2. Age 18-45
- •3. Body mass index (BMI) = 30 kg/m2
- •4. Diagnosis of PCOS based on the NIH Criteria. Require ALL of the following:
- •4.1. Menstrual irregularity (anovulation or >35 day cycle)
- •4.2. Clinical or biochemical hyperandrogenism
- •4.3. Exclusion of other causes other aetiologies of menstrual dysfunction (e.g. thyroid dysfunction, hyperprolactinaemia)
- •5. Insulin resistance as defined by a 2-hour oral glucose tolerance test glucose concentration of 7.8 mmol/l and/or HOMA-IR = 3.0.
- •6. Willing to comply with study requirements and able to give informed consent
排除标准
- •1. Type 1 or Type 2 diabetes mellitus
- •2. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer. These includes:
- •2.1. Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.)
- •2.2. Previous gastrointestinal surgery that could affect the ability to treat the duodenum such as subjects who have had a Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
- •2.3. History of chronic or acute pancreatitis
- •2.4. Known active hepatitis or active liver disease
- •2.5. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn’s Disease and Celiac Disease
- •2.6. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
- •2.7. Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
- •2.8. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
- •2.9. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4-weeks post procedure phase
- •2.10. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
- •2.11. Persistent anaemia, defined as haemoglobin< 10 g/dl
- •2.12. eGFR < 30 ml/min/1.73m2
- •2.13. Active systemic infection
- •2.14. Active malignancy within the last 5 years
- •2.15. Poor candidates for surgery or general anaesthesia
- •2.16. Active illicit substance abuse or alcoholism
- •3. Medications affecting insulin sensitivity (oral steroids, metformin, thiazolidinediones, atypical antipsychotics, hormonal contraceptives, weight loss medication) at screening or 6 months previously.
- •4. Other causes of anovulation (e.g. hypothyroidism, adrenal or pituitary disorders)
- •5. More than 6 menstrual bleeds within the previous 12 months
- •6. Current pregnancy or breastfeeding at screening or 6 months previously
- •7. Smoking at screening or 6 months previously
- •8. Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study
- •9. Donated blood during the preceding 3 months or intention to do so before the end of the study
- •10. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
研究者
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