Clinical trial NCT04949958: Effects of Exercise Based Manual in Sedentary Prediabetic Population
Official title: Effects of Exercise Based Manual on Biochemical, Cardiorespiratory and Physical Parameters in Sedentary Prediabetic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetic
Exercise intervention
Biochemical parameters
Cardiorespiratory parameters
Physical parameters
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Exercise Based Manual (Supervised) Supervised exercise based Manual (exercise \& Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of combination of different exercises including warm up and rest interval

Experimental: Exercise Based Manual (Home Based) Home Based- Exercise Manual (Exercise \& Educational Component) for 16 weeks. Subject will be asked to maintain a regular exercise and dietary education to ensure adherence to the program

Placebo Comparator: Control Age matched Control Group followed for 16 weeks with General Advise to be active.
Primary purpose: PREVENTION

Brief summary: The prediabetes is a state in which fasting blood glucose level ranges between 100-126mg/dl or HbA1C ranges between 5.7-6.4mmol. People with prediabetes have 74 percent chance of progression to develop Type 2 diabetes mellitus. However, by lifestyle intervention, Type 2 Diabetes mellitus may be effectively avoided or delayed. The improvement in lifestyle is involving the physical activity of at least 150mins per week lowered the rate of T2DM in people with prediabetes by 58 percent. There are several risk factors for the development of type 2 diabetes mellitus, but obesity and lack of physical activity are major risk factors that cause type 2 diabetes mellitus in prediabetic populations. Diet and exercise are the first line treatment for sedentary prediabetics. Both independent and combined effect of diet and exercise can reduce the incidence of T2DM, glycemic control and weight loss in adults with prediabetics

Detailed description: The most alarming public health issues of the 21st century is epidemic of diabetes especially in lower middle-income countries. There will be a 67 percent raise in prevalence of diabetes from 2010 to 2030 .With up to half of deaths occurring in people under the age of 60 is due to diabetes as T2DM is among the top ten causes of death.According to American Diabetic Association, if Fasting blood glucose level falls between \<100mg/dl or HbA1C falls between \<5.7% then person has normal blood sugar level if Fasting blood glucose level falls between 100-125mg/dl or HbA1C falls between 5.7%-6.4% then person is diagnosed as prediabetic and if value of fasting blood glucose level falls between 126-200mg/dl and HbA1C more than 6.5% then person is diagnose as Type 2 Diabetes mellitus.

Prediabetes is a state in which the body can maintain blood glucose level but impaired insulin sensitivity is still present.Worldwide there is a 74 percent chance of progression of prediabetes into Type 2 Diabetes Mellitus. Strategies for prevention of T2DM are highly recommended for sedentary population.There are now estimated 38 million adults living with diabetes around the world. The main cause of premature death in the world with ration of every 6 into 10 due to the effects of diabetes and diabetes-related complications.

Pakistan is now in the top 10 countries with increase in the incidence of diabetes. According to WHO, around 19 million people are diagnosed with diabetes and 10 million people are diagnosed as prediabetics. An estimated 463 million adults worldwide live with diabetes and 55 million live with prediabetes. However there are some risk factors for T2DM that can be modifiable including obesity, metabolic syndrome characteristics (abdominal obesity, elevated triglycerides, low density lipoprotein), high blood pressure and elevated plasma glucose, insulin resistance, sedentary lifestyle Exercise intervention requires repetitive body movements performed to enhance or sustain one or more physical fitness components such as aerobic ability, muscle strength and endurance, flexibility. Sedentary lifestyle is associated with an increased risk of death, cardiovascular disease and increase the incidence of T2DM which is mostly recognized in young adult population.Physical exercise facilitates improved functioning of the human body. Regular exercise enhances insulin sensitivity thus helping to avoid diabetes.Exercise training is known to increase the absorption of insulin-mediated skeletal muscle glucose and blood flow to limbs thus leading to reduction in glycemic control in diabetic population.

Eligibility criteria: Inclusion Criteria:

* Serum glucose test indicating prediabetic (HbA1c level of 5.7% - 6.4% or fasting plasma glucose of 100 - 12
* Sedentary Subjects (\<150 min/week or \<600 MET-min/week on IPAQ Urdu Version)

Exclusion Criteria:•

* History of type 2 diabetes mellitus or newly diagnosed diabetes within last 6 months
* BMI under 18.5 and more 30
* Persons involve in other weight management program,
* History of taking any herbal medications to control the weight
* Clinical history of cardiovascular diseases occurred within the past six months
* Pregnancy

Primary outcomes:
measure: Hemoglobin A1c Test (HbA1C0
timeFrame: 16 week
measure: Fasting blood Glucose(FBG)
timeFrame: 16 weeks
measure: Homeostasis model assessment of β-cell function(HOMA-β)
timeFrame: 16 weeks
measure: Homeostatic Model Assessment for Insulin Resistance(HOMA-IR)
timeFrame: 16 weeks
measure: low-density lipoproteins(LDL)
timeFrame: 16 weeks
measure: high-density lipoproteins( HDL)
timeFrame: 16 weeks
measure: Triglycerides
timeFrame: 16 weeks
measure: Maximal oxygen consumption( VO2max)
timeFrame: 16 weeks
measure: Rate of perceived exertion( PRE)
timeFrame: 16 weeks
measure: Baseline Dyspnea Index(BDI)
timeFrame: 16 weeks
measure: weight in kilograms
timeFrame: 16 weeks
measure: Body mass index (BMI)
timeFrame: 16 weeks
measure: waist circumference
timeFrame: 16 weeks
measure: waist to hip ratio (WHR)
timeFrame: 16 weeks
measure: Body fat percentage
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabiliation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil ur Rehman, PhD
role: STUDY_CHAIR
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