2025-523214-83-00招募中4 期
The effect of transdermal 17-β-estradiol/progesterone supplementation on glucose regulation in peri- and postmenopausal women with type 1 and type 2 diabetes
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The main endpoint is the difference in the 14-day glucose time-in-range (TIR) during the final two weeks of treatment with estradiol/progesterone compared to the control period.
研究概览
简要总结
The primary objective is to determine the effect of transdermal 17-β-estradiol combined with oral micronized progesterone on glucose regulation in peri- and early postmenopausal women with diabetes mellitus (type 1 or 2) and climacteric symptoms.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Late perimenopausal, defined as changes in the menstrual cycle with an interval of amenorrhea of >= 60 days (STRAW+10 stage –1) OR early postmenopausal (STRAW+10 stage +1), defined as final menstrual cycle more than 1 years prior to inclusion.
- •Final menstrual cycle < 5 years prior to inclusion
- •One or more menopause-associated symptoms. For example: vasomotor symptoms (hot flushes and sweats), musculoskeletal symptoms (joint and muscle pain), effects on mood (low mood), sexual difficulties (low sexual desire)
- •Additionally, for T1DM: Diabetes Mellitus type 1 diagnosed before menopause, and at least 6 months prior to the study
- •Additionally, for T2DM: Diabetes Mellitus type 2 diagnosed before menopause, and at least 6 months prior to the study
- •Additionally, for T2DM: Use of insulin, at least 1 time daily
排除标准
- •Contra-indication for transdermal estrogen and/or progesterone therapy: Presence or sus-picion or history of breast cancer, endometrial cancer, ovarian cancer, presence or history of venous thromboembolism (unless the individual is using anticoagulation therapy), active arterial thrombosis or in the past 6 months (e.g. myocardial infarction, angina pectoris) in-herited or acquired thrombophilia, acute liver disease, or a history of liver disease as long as liver function values have not normalized, untreated endometrial hyperplasia, abnormal vaginal bleeding, porphyria, uncontrolled or severe hypertension.
- •Chronic kidney disease defined as eGFR < 30 mL/min/1.73m2
- •Additionally, for T1DM: Use of glucose-regulating medications other than insulin, such as metformin, GLP-1/GIP re-ceptor agonists, sulfonylureas, SGLT2 inhibitors, and DPP4 inhibitors
- •Additionally, for T2DM: Changes to glucose-regulating medications (metformin, GLIP-1/GIP receptor agonists, sulfonylureas, SGLT2 inhibitors, DPP4 inhibitors) other than insulin, including starting, stopping or altering the dosage, in three months prior to the study period. (Note that these medications may be used, provided they are not changed three months prior to the study.)
- •Participants with BRCA1 or 2 gene or PTEN mutation
- •Participants with a first degree relative with (a history of) breast cancer
- •Known hypersensitivity to the excipients in the estradiol patch: acrylate copolymer, poly-ethylene terephthalate, α-tocopherol, or progesterone capsule: soy allergy or peanut aller-gy
- •Hysterectomy
- •Premature menopause (menopause age < 40 years)
- •Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) within three months before inclusion
- •Use of systemic glucocorticosteroids less than 1 month prior to the study or anticipated need for systemic steroids during the study period (e.g., for Crohn’s disease or astma/COPD). Incidental use of topical agents is allowed.
- •Active malignancy or history of treated cancer within 24 months of enrollment
结局指标
主要结局
The main endpoint is the difference in the 14-day glucose time-in-range (TIR) during the final two weeks of treatment with estradiol/progesterone compared to the control period.
The main endpoint is the difference in the 14-day glucose time-in-range (TIR) during the final two weeks of treatment with estradiol/progesterone compared to the control period.
次要结局
- Glucose regulation parameters: change in time-below –range (TBR, %), time-above-range (TAR, %), glycaemic variability (coefficient of variation [CV]), and mean glucose measured using 14 days of blinded CGM after 12 weeks of estradiol/progesterone versus 12 weeks of no intervention.
- Change in serum HbA1c, carbohydrate-insulin ratio (CIR), daily insulin dose
- Insulin sensitivity (whole body and adipose tissue) measured by hyperinsulinemiceuglycemic clamp. Whole body insulin sensitivity will be expressed as the ratio of M – value and insulin concentration: M / I. M – value in mg / kg / min and I in uIU/uL. Adipose tissue insulin sensitivity will be expressed as the suppression of plasma free fatty acid concentration in %.
- Cardiovascular risk: change in lipid profile and 24-hour blood pressure
- Change in liver steatosis using the CAP score assessed with fibroscan and for participants with T2DM total liver fat assessed with MRI-PDFF
- Change in handgrip strength using handgrip dynamometry
- Change in climacteric symptoms (Greene Climacteric Scale questionnaire), quality of sleep (Insomnia severity index), depressive symptoms (Hospital Anxiety and Depression Score), diabetes distress (Problem Areas In Diabetes), and quality of life (WHO-5).
研究者
Department of endocrinology and metabolism
Scientific
Amsterdam UMC Stichting
研究点 (1)
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