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Clinical Trials/NCT05110404
NCT05110404
Completed
Not Applicable

EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES

Cairo University1 site in 1 country72 target enrollmentDecember 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Cairo University
Enrollment
72
Locations
1
Primary Endpoint
fasting & 2-h post prandial blood glucose
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?

Purpose of the study:

To assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.

Null Hypothesis:

There will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
December 25, 2021
End Date
May 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asmaa Mohamed Mahmoud Mohamed

physiotherapist holds a master's degree in Physical therapy for Cardiovascular, Respiratory disorders and geriatrics, Faculty of physical therapy, Cairo university.

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Type II diabetes mellitus diagnosed by a physician as having HbA 1c of \> 6.5%.
  • An established diagnosis of T2DM for at least 1year and less than 5 years.
  • Women patients.
  • Age between 35 to 45 years old.
  • Systolic Blood pressure less than or equal 130 mmHg.
  • Obese patients (BMI is between 30 and 39.9 kg/m 2 )
  • Patients with HbA 1c of 7-9%.
  • A self-reported sedentary lifestyle.
  • Patients receiving oral hypoglycemic medications described by the physician
  • Patients with hyperlipidemia.

Exclusion Criteria

  • Patients with Cardiac diseases.
  • Patients with glaucoma.
  • Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
  • Musculoskeletal or neurological limitations to physical exercise.
  • Patients under insulin therapy
  • Patients with poorly controlled DM (HbA1c \> 9%)
  • Bronchial asthma and chronic obstructive pulmonary disease.
  • Morbidly obese BMI ≥ 40 kg/m 2
  • Systolic Blood pressure more than 130 mmHg.
  • Anemia ( hemoglobin \< 12 g/dL)

Outcomes

Primary Outcomes

fasting & 2-h post prandial blood glucose

Time Frame: 12 weeks

change in fasting \& 2-h post prandial blood glucose

body mass index

Time Frame: 12 weeks

change in body mass index

waist circumference

Time Frame: 12 weeks

change in waist circumference

waist/hip ratio

Time Frame: 12 weeks

change in waist/hip ratio

Systolic and diastolic blood pressure

Time Frame: 12 weeks

change in Systolic and diastolic blood pressure

HbA1c

Time Frame: 12 weeks

change in HbA1c

fasting lipid profile

Time Frame: 12 weeks

change in fasting lipid profile

Study Sites (1)

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