High Intensity Interval Training in Pre and Postmenopausal Women With Type II Diabetes.

NCT07258316 | Recruiting

• 1 other identifier: Mushafaeen Rizwan
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Postmenopausal Symptoms

Outcome Measures

Primary Outcomes (7)

• HbA1c

  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%

  Baseline and 8 weeks

• Fasting Blood Glucose

  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)

  Baseline and 8 weeks

• Fasting Insulin

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

  Baseline and 8 week

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

  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

  Baseline and 8 week

• CRP

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

  Baseline and 8 week

• QUICKI (Quantitative Insulin Sensitivity Check Index)

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

  Baseline and 8 week

• HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

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

  Baseline and 8 week

Study Arms (2)

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.

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

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

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

Interventions

High Intensity Interval Training (warm up, Mat exercises,cycling,HIIT exercises,cool down) OTHER

This will include 8 weeks of plan with total 27 sessions 3 times a week and each session will include warm up exercises ( Treadmill (Incline and Reverse), Mat Exercises (Cobra, Cat/camel stretches, Superman, Aeroplane and Skydiving exercises)and Cycling (Seated and un-supported). this will be of 10-15 minutes. Then HIIT exercises which includes High knees, Push ups, Russian crunches, Battle ropes, Weighted squats, Planks, Seated rows and Jumping jacks. Then cool- down exercises will be of 10-15 minutes and this will includes Full body Stretches (Quadriceps, Hamstrings, Piriformis, Calfs, Biceps, Triceps, Rhomboids, IT band, Trapezius, and Chest Stretches), whole exercise plan will take 60-90 minutes.

High Intensity Interval Training group

Control (warm up, Mat exercises,cycling,Resistance exercises,cool down) OTHER

This group will includes also recieve 8 weeks of exercises plan for 3/week warmup exercises same as the experimental group such as Treadmill (Incline and Reverse), Mat Exercises (Cobra, Cat/camel stretches, Superman, Aeroplane and Skydiving exercises)and Cycling (Seated and un-supported) forv about 10-15 miutes Resistance Exercises like (LAT Pull down, Leg Curls, Leg Extension, Hips Adductor/ Abductors, Seated Rowing, Rear deltoid machine). the progression will be increased gradually. Cool down exercises includes full body streching and the whole session will be of 60-90 minutes

Control group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ginnastic Health Centre, Islamabad

Islamabad, Islamabad Capital Territory, Pakistan, 44000, Pakistan

RECRUITING

Related Publications (3)

• Motahari-Tabari N, Ahmad Shirvani M, Shirzad-E-Ahoodashty M, Yousefi-Abdolmaleki E, Teimourzadeh M. The effect of 8 weeks aerobic exercise on insulin resistance in type 2 diabetes: a randomized clinical trial. Glob J Health Sci. 2014 Aug 14;7(1):115-21. doi: 10.5539/gjhs.v7n1p115.

  PMID: 25560330 BACKGROUND

• Mandrup CM, Egelund J, Nyberg M, Enevoldsen LH, Kjaer A, Clemmensen AE, Christensen AN, Suetta C, Frikke-Schmidt R, Steenberg DE, Wojtaszewski JFP, Hellsten Y, Stallknecht BM. Effects of menopause and high-intensity training on insulin sensitivity and muscle metabolism. Menopause. 2018 Feb;25(2):165-175. doi: 10.1097/GME.0000000000000981.

  PMID: 28953212 BACKGROUND

• Cybulska AM, Schneider-Matyka D, Wieder-Huszla S, Panczyk M, Jurczak A, Grochans E. Diagnostic markers of insulin resistance to discriminate between prediabetes and diabetes in menopausal women. Eur Rev Med Pharmacol Sci. 2023 Mar;27(6):2453-2468. doi: 10.26355/eurrev_202303_31779.

  PMID: 37013763 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval Training; Warm-Up Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Huma Riaz, PhD

  Riphah Itnernational University, Islamabad Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Huma Riaz, PhD

CONTACT

+923215242874; huma.riaz@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be comparison between the two groups, experimental and control

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: December 2, 2025
• Study Start: September 25, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)