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NCT Number: NCT03716336

Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women

A total of 42 premenopausal women diagnosed clinically as having insulin resistance. Their ages ranged from 35 to 45 years old; their body mass index was >30 kg/m2 and They were obese women complained of insulin resistance and non diabetic or cardiovascular disease, were randomly assigned to group A participated in aerobic & resistive exercise program, and group B participated in aerobic exercise and followed prescribed diet restriction program. Both of the groups (A&B) followed the treatment program 3 times per weeks for 8 weeks. Assessment of the fasting glucose, fasting insulin, and HOMA test of insulin resistance were measured for all subjects in both groups (A and B) was carried out before and after the end of the treatment program

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Key information

Conditions

Insulin Resistance Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy- Cairo University

Giza, Dokki, 12613, Egypt

About this study

Forty two obese premenopausal women diagnosed as having insulin resistance were participated in this study. They were selected randomly from the out Patient Clinic of Obstetrics at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University. Their age ranged from 35 - 45years, their body mass (BMI) were>30kg/m2. Exclusion criteria of the study were as follows: Patients having diabetic or cardiovascular disease, Patients with life threatening disorders as renal failure and myocardial infarction, Patients with active malignancy and patients with severe hemorrhage, hyperthyroidism, acute viral diseases and mental disorders. Participants were assigned randomly used sealed envelope into two groups (A&B) equally in number. Group (A): (Combined resistive and aerobic exercise group) consisted of 20 women were participated in aerobic & resistive exercise program plus diet restriction, 3 times per weeks for 8 weeks. Group (B): consisted of 20 women were participated in aerobic exercise plus diet restriction 3 times per weeks for 8 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Their age ranged from 35 - 45years.
  • their body mass (BMI) were>30kg/m2.

Exclusion criteria

  • Patients having diabetic or cardiovascular disease.
  • Patients with life threatening disorders as renal failure and myocardial infarction
  • Patients with active malignancy.
  • patients with severe hemorrhage
  • hyperthyroidism.

Treatment and study plan

Resistance Exercise

Other

Resistance exercise were performed for all participants in group (A) only included 9 exercise for big muscles of upper limbs (shoulder flexors muscles, shoulder extensors and shoulder abductors), lower limbs (hip flexors, hip extensors and knee flexors and knee extensors) and abdominal muscle using moderate work load (60 - 75% of IRM) 1set of 10 repetitions, progressing to 2 sets of 10 repetitions after four weeks for 20 minutes

Aerobic Exercise

Other

aerobic exercise were performed on treadmill. For 20 minutes. All patients in both groups (A,B) had attended the program of a resistance exercises and followed by aerobic exercise for 8 weeks in form of 20 minutes walking on the treadmill without inclination.

Other names: exercise

diet restriction

Dietary Supplement

All participants in both groups (A,B) were instructed to follow a moderate restricted diet limited to (1800-2000) kcal/ day under supervision of a certified dietician. The diet contained: Protein and fibers: 20% carbohydrate: 50-60%, fat: low 20%.

Primary outcomes

  1. HOMA test of insulin

    Time frame: 8 weeks

    A sample of 5ml of venous blood sample was drawn from the ante cubital vein after 10 hours fasting from all women in the two groups (A, B) for measurement of fasting blood glucose, fasting blood insulin and detection of insulin resistance (by HOMA-IR)

Secondary outcomes

  1. fasting blood insulin level

    Time frame: 8 weeks

    A sample of 5ml of venous blood sample was drawn from the ante cubital vein after 10 hours fasting from all women in the two groups (A, B) for measurement of fasting blood insulin

  2. fasting blood glucose level

    Time frame: 8 weeks

    A sample of 5ml of venous blood sample was drawn from the ante cubital vein after 10 hours fasting from all women in the two groups (A, B) for measurement of fasting blood glucose

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Impact of Concurrent Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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