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妙佑医疗国际The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study
- 25-001692
menopause
Tirzepatide
GLP
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Tirzepatide Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations | Tirzepatide Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg.
Participants will be asked to follow lifestyle interventions:
* Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day
* Physical activity: a goal of 10,000 steps or more per day
* Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week
* Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.). |
安慰剂对照Placebo Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations | 安慰剂 A placebo for Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg.
Participants will be asked to follow lifestyle interventions:
* Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day
* Physical activity: a goal of 10,000 steps or more per day
* Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week
* Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.). |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in Vasomotor Symptoms Frequency | Change in the frequency of self-reported daily average vasomotor symptoms from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and 2 weeks at the end of the study. | Baseline, 24 weeks |
Change in Vasomotor Symptom Severity | Change in self-reported daily vasomotor symptom severity from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and at the end of the study. Severity will be classified as follows:
Mild, sensation of heat without sweating/dampness; Moderate: sensation of heat with sweating/dampness, but able to continue current activity. May briefly fan yourself; Severe: sensation of intense heat with sweating causing disruption of current activity. | Baseline, 24 weeks |
Aging Biomarkers: Cellular Senescence Markers in Plasma | Cellular senescence markers are measured in plasma samples to assess biological aging and cellular stress. These markers may include proteins associated with the senescence-associated secretory phenotype (SASP). Quantification is performed using immunoassays. Higher levels of senescence markers indicate increased cellular senescence. | 24 weeks |
Difference between biological and chronological age | Epigenetic clocks estimate biological age by analyzing DNA methylation patterns at specific CpG sites across the genome. Biological age estimates are compared to chronological age to assess aging acceleration or deceleration. Biological age greater than chronological age indicates accelerated biological aging and potential increased risk of morbidity and mortality. Primary measure is the difference (ΔAge) between biological and chronological ages = reported in years. | 24 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in Vascular Function | Vascular function will be measured using the EndoPAT device to assesses reactive hyperemia index (RHI) from baseline to week 24 on treatment or placebo. RHI is automatically calculated through a computer algorithm by following the equation: \[(tested arm-post occlusion/tested arm-baseline)/(control arm-post occlusion/control arm-baseline)\] × baseline correction factor. Endothelial dysfunction is defined as having an RHI ratio of \<1.67. | Baseline, 24 weeks |
Change in Cardiometabolic Parameters: Blood Pressure | Change in cardiometabolic parameters including blood pressure from baseline to week 24 on treatment or placebo. Measured in mmhg | Baseline, 24 weeks |
Change in Cardiometabolic Parameters: Fasting Glucose | Change in cardiometabolic parameters including fasting glucose from baseline to week 24 on treatment or placebo. Measured in mg/dL | Baseline, 24 weeks |
Changes in Cardiometabolic Parameters: HbA1C | Change in cardiometabolic parameters including HbA1C from baseline to week 24 on treatment or placebo. Measured in % | Baseline, 24 weeks |
Changes in Cardiometabolic Parameters: Lipoprotein profile | Change in cardiometabolic parameters including Lipoprotein profile from baseline to week 24 on treatment or placebo. Measured in mg/dL | Baseline, 24 weeks |
Changes in Cardiometabolic Parameters: hsCRP | Change in cardiometabolic parameters including hsCRP from baseline to week 24 on treatment or placebo. Measured in mg/L | Baseline, 24 weeks |
- Postmenopausal women defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Age 46-60 years old.
- BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
- Presence of bothersome hot flashes (≥ 28 episodes per week and of sufficient severity to prompt patients to seek therapeutic interventions).
- Hot flashes must be present for >30 days prior to study entry.
- Ability to participate in all portions of the study, including willingness to self-inject drug
- Provided informed consent to be part of the study.
- Willingness and capability to follow a hypocaloric diet, consisting of an energy deficit of approximately 500 kcal/day compared to baseline total energy expenditure, and composed of 30% from fat, 20% from protein, and 50% of carbohydrate. In addition to performing at least 150 min/week of physical activity
Current treatment with menopausal hormone therapy.
Any current (past 4 weeks) or planned use of:
- Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).
- Vaginal estrogen.
- Androgens.
- Progestogens.
Current treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.
Current use of fezolinetant.
Menopause as a result of cancer treatments.
Impaired renal function (GFR ≤30 ml/min/1.73 m²).
Thyroid-stimulating hormone ≥7 with low free T4.
10-year ASCVD risk > 7.5%.
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.
>5% change in weight during the 3 months prior to screening and, or eight fluctuation of ≥20 pounds within the past 6 months (self-report).
Other obesity medication used within the past 3 months.
History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed > 1 year before screening).
Past or intended endoscopic and/or device-based therapy or removal within last six months.
Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.
Contraindications to GLP-1 receptor agonist therapy as per Tirzepatide (Zepbound ®) label, including a personal or family history of medullary thyroid carcinoma; a history or diagnosis of multiple endocrine neoplasia syndrome type 2; known hypersensitivity to tirzepatide or any of its excipients.
Currently enrolled in another clinical study involving an investigational product, or participated in one and received treatment (active or placebo) in the last 30 days.
Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.
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