Clinical trial NCT05110404: COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING
Official title: EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: DM
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with Cardiac diseases.
2. Patients with glaucoma.
3. Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
4. Musculoskeletal or neurological limitations to physical exercise.
5. Pregnancy
6. Patients under insulin therapy
7. Patients with poorly controlled DM (HbA1c \&gt; 9%)
8. Bronchial asthma and chronic obstructive pulmonary disease.
9. Smokers.
10. Morbidly obese BMI ≥ 40 kg/m 2
11. Males.

11. Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin \&lt; 12 g/dL) 13. Osteopenia.

Primary outcomes:
measure: body mass index
timeFrame: 12 weeks
measure: waist circumference
timeFrame: 12 weeks
measure: waist/hip ratio
timeFrame: 12 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12 weeks
measure: fasting & 2-h post prandial blood glucose
timeFrame: 12 weeks
measure: fasting lipid profile
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy cairo University
Study officials:
References: