Clinical trial NCT03716336: Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women
Official title: Impact of Concurrent Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance Syndrome
Keywords: resistive exercises
aerobic exercises
diet
insulin resistance
premenopausal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: were randomly assigned to group A participated in aerobic and 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.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HOMA test of insulin
timeFrame: 8 weeks
Secondary outcomes:
measure: fasting blood insulin level
timeFrame: 8 weeks
measure: fasting blood glucose level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy- Cairo University
state: Dokki
Study officials:
affiliation: institutional review board of the Faculty of physical therapy, Cairo University
name: ghada eb elrefaye, professor
role: PRINCIPAL_INVESTIGATOR
References: