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临床试验/NCT07258316
NCT07258316招募中不适用

Comparative Effects of High-Intensity Interval Training in Pre and Postmenopausal Women With Type II Diabetes Mellitus

Riphah International University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
HbA1c

研究概览

简要总结

Diabetes Mellitus (DM), a chronic metabolic disease-causing chronic hyperglycemia. Globally more than 90% cases are of type II diabetes mellitus (T2DM). Around 537 million adults worldwide had diabetes but according to data from Pakistan, female sufferers are marginally higher (26.4%) as compared to men (25.1%). The main causes of DM II are genetic predispositions, including consanguinity, dietary changes, urbanization and sedentary lifestyles. It is reported that postmenopausal status is linked to worsened glycemic control, increased visceral adiposity and and inflammation, and women before menopause generally have improved lipid metabolism and insulin sensitivity. HIIT provides powerful and time-efficient benefits by alternating high-intensity workouts (85-95% HR_Max) with recovery.

详细描述

Diabetes Mellitus (DM), is linked to impaired protein, lipid and carbohydrate metabolism, as well as impaired insulin secretion or its reduced sensitivity and this number will increase to almost 643 million by 2030 and 783 million by 2045. As estimated by the International Diabetes Federation (2021), the burden of DM type II is especially severe in Pakistan, where 33 million adults are affected by it, ranking Pakistan at number three globally. A study published in January 2025 in BMC Public Health found that the DALY burden of type 2 diabetes in Asian women was approximately 7,122 per 100,000, with behavioral risk factors (air pollution, fasting plasma glucose, and dietary risks) playing a significant role. The Study of Women's Health across the Nation (SWAN) cohort showed that Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) levels rose steadily during menopause this means that insulin resistance gets a lot worse for women during menopause. While another study reported that postmenopausal women have comparatively increased Low Density Lipo-protein (LDL) cholesterol, triglycerides, decreased high-density lipoprotein (HDL) cholesterol, increased C-Reactive Protein (CRP) and Interleukin-6 (IL-6), the markers of cardio-metabolic risk, as compared to premenopausal women. As estradiol deficiency is linked to decreased adiponectin and increased leptin, these hormonal changes also upset the balance of adipokines, exacerbating insulin resistance and inflammatory signaling pathways. After age 45, the odds ratio (OR) of getting T2DM was about 0.13, and the risks stopped rising after age 50-55. The key to managing type 2 diabetes is physical activity. Insulin sensitivity, systemic inflammation, fasting glucose, and HbA1c are all improved by conventional aerobic exercise. High-intensity interval training (HIIT) and other interventions meant to improve insulin sensitivity and inflammatory status. HIIT improves mitochondrial function, decreases inflammation, changes the distribution of body fat, and increases muscle glucose uptake to help manage type 2 diabetes in premenopausal and postmenopausal women. HIIT therefore enhances insulin sensitivity and glycemic control. According to meta-analyses, adults with type 2 diabetes who receive 8-12 weeks of HIIT experience significant decreases in their HbA1c (0.3-0.8%), fasting insulin (~20-30%), and CRP (~15-25%). In another study HIIT protocol were applied on the PCOS women with hormonal imbalances and metabolic issues Running at 100-110% of maximum aerobic velocity (MAV) was part of the training regimen, which was divided into 4-6 sets of 4 laps. For eight weeks, participants trained three times a week. The goal of this intense training program was to improve aerobic capacity and performance. Diabetes is prevalent worldwide; postmenopausal women are more vulnerable because of metabolic and hormonal changes. Previous studies have not much inquired the effect of glycemic control in varying menopausal status, although effectiveness of HIIT is proven for improving in insulin sensitivity and CRP in women and is considered a promising modality, but there is need to determine its effectiveness across women of varied menopausal status with T2DM. The aim of the study is to evaluate the effects of HIIT on glycemic control, Inflammatory markers, and Insulin sensitivity in pre versus postmenopausal women with T2DM and to support culturally appropriate menopause-sensitive exercise recommendations for women with T2DM.High-Intensity Interval Training (HIIT) provides a quick, non-pharmacological method to enhance insulin sensitivity, blood sugar regulation, body composition, and heart health, , this study intends to investigate how HIIT can specifically help manage blood sugar problems associated with hormonal changes associated with menopause.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female patients aged 40-65 years with physician-diagnosed T2DM.
  • •Premenopausal (regular menstruation) or postmenopausal (≥12 months amenorrhea) (self-reported).
  • •Participants who have not engaged in any structured exercise sessions or gym workouts in the past six months.
  • •Willing to follow supervised HIIT protocol and provide informed consent.

排除标准

  • •Cardiovascular, orthopedic, or endocrine conditions contraindicating exercise.
  • •Current use of insulin or hormone replacement therapy.
  • •Participation in structured exercise programs in the past 6 months.
  • •Cognitive impairment or psychiatric illness

研究组 & 干预措施

High Intensity Interval Training group

Experimental

The group will receive 8 weeks of High Intensity Interval Training (27 sessions, 3/week, 60-90 minutes). Progresssion for 1-4 weeks will of Workout Interval : Rest Interval will be 30 sec : 30 sec of each exercise and from week 5-8 the progression will be 30 sec : 15 sec. Both Warm-up and Cool down exercises will be of 10-15 minutes.

干预措施: High Intensity Interval Training (warm up, Mat exercises,cycling,HIIT exercises,cool down) (Other)

Control group

Active Comparator

This group will receive Resistance Exercises with alternate days 3 times per week for 8 weeks and total sessions will be 27. Both warmup and cool down will be of 10-15 minutes and progression will be increased gradually. This group will include different Resistance Exercises and the time duration will be 60-90 minutes

干预措施: Control (warm up, Mat exercises,cycling,Resistance exercises,cool down) (Other)

结局指标

主要结局

HbA1c

时间窗: Baseline and 8 weeks

For monitoring long-term glycemic control, the average blood glucose over the past 2-3 months. its values range from Normal: \< 5.7%, Prediabetes: 5.7% - 6.4%, Diabetes: ≥ 6.5%

Fasting Blood Glucose

时间窗: Baseline and 8 weeks

For Assessing short-term blood sugar control, used for onitoring glucose levels in metabolic disorders and Screening for insulin resistance or hypoglycemia.. Normal: 70 - 99 mg/dL (3.9 - 5.5 mmol/L), Prediabetes: 100 - 125 mg/dL (5.6 - 6.9 mmol/L), Diabetes: ≥ 126 mg/dL (≥ 7.0 mmol/L)

Fasting Insulin

时间窗: Baseline and 8 week

Evaluating insulin resistance and sensitivity also use to monitoring and managing diabetes). Normal: 2 - 20 µU/mL

Basic Lipid Profile testing including total cholesterol, Low-Density Lipoprotein-Cholesterol,High-Density Lipoprotein-Cholesterol and Triglycerides.

时间窗: Baseline and 8 week

these are validated blood tests for diagnosing dyslipidemia. A lipid profile's normal ranges, in mg/dL, are: Total Cholesterol: \< 200, LDL (Bad) Cholesterol: \< 100 (or \< 70 for those with diabetes), HDL (Good) Cholesterol: \> 60, and Triglycerides: \< 150

QUICKI (Quantitative Insulin Sensitivity Check Index)

时间窗: Baseline and 8 week

Normal value ≥ 0.33. * Estimating insulin sensitivity (higher = better sensitivity) * An alternative to HOMA-IR, especially in research settings.

CRP

时间窗: Baseline and 8 week

for Detecting and monitoring inflammation in the body) Normal: \< 10 mg/L Elevated: \> 10 mg/L

HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

时间窗: Baseline and 8 week

Normal value \< 2 * Estimating insulin resistance (higher = more resistance) * Early detection of metabolic syndrome, prediabetes, or type 2 diabetes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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