PreDiabetesNCT04949958
Effects of Exercise Based Manual in Sedentary Prediabetic Population
A study testing Exercise Based Manual (Supervised) and Exercise Based Manual (Home Based) in people with PreDiabetes, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Exercise Based Manual (Supervised) and Exercise Based Manual (Home Based)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Based Manual on Biochemical, Cardiorespiratory and Physical Parameters in Sedentary Prediabetic Population
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
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Exercise Based Manual (Supervised), Exercise Based Manual (Home Based), Control
- Keywords
- Prediabetic, Exercise intervention, Biochemical parameters, Cardiorespiratory parameters, Physical parameters
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Based Manual (Supervised)Other
Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise, Exercise and Education. The exercise will be supervised while other component will be home based.
Exercise Based Manual (Home Based)Other
Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise and Education. All two components will be home based.
ControlOther
General advice to be active
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Exercise Based Manual (Supervised) | Experimental | Supervised Exercises with exercise based Manual (exercise \& Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of different type of exercises including warm up and rest interval Receives: Other: Exercise Based Manual (Supervised) |
| Experimental: Exercise Based Manual (Home Based) | Experimental | 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. Receives: Other: Exercise Based Manual (Home Based) |
| Placebo Comparator: Control | Placebo comparator | Age matched Control Group followed for 16 weeks with General Advise to active Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c Test (HbA1C0
Hemoglobin A1c Test tells you average level of blood sugar over the past 2 to 3 months.The normal range for the hemoglobin A1c level is between 4% and 5.6% and readings will be taken at baseline,8th week and 16 week.
Measured: 16 week
Fasting blood Glucose(FBG)
This test checks your fasting blood sugar levels. Fasting means after not having anything to eat or drink (except water) for at least 8 hours before the test. Normal value will be less than 100 mg/dl and Prediabetes value 100 mg/dl to 125 mg/dl.Reading will be taken after 8 hour fasting. Readings will be taken at baseline,8th week and 16 week
Measured: 16 weeks
Homeostasis model assessment of β-cell function(HOMA-β)
The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations.It is calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).Sample will be taken from intravenous blood sample \& readings will be taken at baseline and at 16 weeks.
Measured: 16 weeks
Homeostatic Model Assessment for Insulin Resistance(HOMA-IR)
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. Healthy Range: 1.0 (0.5-1.4).Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. sample will be taken from intravenous blood sample \& readings will be taken at baseline and at 16 weeks.
Measured: 16 weeks
low-density lipoproteins(LDL)
low-density lipoproteins sometimes called the "bad" cholesterol Value Less than 100mg/dL is Optimal, value 100-129mg/dL Near optimal/above optimal,Value 130-159 mg/dL Borderline high. Reading will be taken at baseline,8th week and at 16 weeks of intervention.
Measured: 16 weeks
high-density lipoproteins( HDL)
high-density lipoproteins sometimes called the "good" cholesterol.HDL that falls within the range of 40 to 59 mg/dL is normal. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
Triglycerides
Triglycerides are a type of fat (lipid) found in your blood. Normal triglyceride levels in the blood are less than 150 mg per deciliter (mg/dL). Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
Maximal oxygen consumption( VO2max)
the maximum or optimum rate at which the heart, lungs, and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.A good VO2 max for a male is 42.5-46.4 mL/kg/min, while a good value for a female is 33.0-36.9 mL/kg/min.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
Rate of perceived exertion( PRE)
The RPE scale is used to measure the intensity of your exercise. The RPE scale runs from 0 - 10. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
Baseline Dyspnea Index(BDI)
Baseline Dyspnea Index (BDI) measures the severity of dyspnea at the baseline Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
weight in kilograms
Weight (symbolized w ) is a quantity representing the force exerted on a particle or object by an acceleration field, particularly the gravitational field of the Earth at the surface.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
Body mass index (BMI)
is a measure of body fat based on height and weight that applies to adult men and women. Below 18.5 is Underweight,18.5-24.9 is Normal,25.0-29.9 is Overweight, 30.0 and Above is Obese. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Measured: 16 weeks
waist circumference
Waist circumference is the measurement taken around the abdomen at the level of the umbilicus (belly button). For best health, waist should be less than 40 inches around for men, and less than 35 inches for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
Measured: 16 weeks
waist to hip ratio (WHR)
Waist too hip ratio is a quick measure of fat distribution that may help indicate a person's overall health. A healthy WHR is: 0.9 or less in men. 0.85 or less for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
Measured: 16 weeks
Body fat percentage
body fat percentage as just one way to assess and monitor your weight and overall body composition.Men Women Average value for men is18%-24% and foe women is 25%-31%.Value for Obese men is 25% and higher, for obese women is 32% and higher. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of body fat analyzer.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start15 Apr 2022
- Primary completion25 Oct 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, PhD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949958
- Sponsor's protocol ID
- REC/Lhr/21/1103 Sana Hafeez
- Status last verified
- Mar 2024
- First submitted
- 26 Jun 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowan CP, Riddell MC, Gledhill N, Jamnik VK. Aerobic Exercise Training Modalities and Prediabetes Risk Reduction. Med Sci Sports Exerc. 2017 Mar;49(3):403-412. doi: 10.1249/MSS.0000000000001135.
PubMed 27776003Williams AN, Konopken YP, Keller CS, Castro FG, Arcoleo KJ, Barraza E, Patrick DL, Olson ML, Shaibi GQ. Corrigendum to 'Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods☆'' [Contemp. Clin. Trials 54 (2017) 68-76]. Contemp Clin Trials. 2018 Aug;71:205. doi: 10.1016/j.cct.2018.06.014. Epub 2018 Jul 7. No abstract available.
PubMed 30064689Aguiar EJ, Morgan PJ, Collins CE, Plotnikoff RC, Callister R. Efficacy of interventions that include diet, aerobic and resistance training components for type 2 diabetes prevention: a systematic review with meta-analysis. Int J Behav Nutr Phys Act. 2014 Jan 15;11:2. doi: 10.1186/1479-5868-11-2.
PubMed 24423095Barengo NC, Tuomilehto J. Diabetes: exercise benefits in type 2 diabetes mellitus. Nat Rev Endocrinol. 2012 Nov;8(11):635-6. doi: 10.1038/nrendo.2012.182. Epub 2012 Oct 2. No abstract available.
PubMed 23032182Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
PubMed 30273708Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
PubMed 24239920Kosaka K, Noda M, Kuzuya T. Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males. Diabetes Res Clin Pract. 2005 Feb;67(2):152-62. doi: 10.1016/j.diabres.2004.06.010.
PubMed 15649575Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.
PubMed 9096977American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
PubMed 22187469
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Based Manual on Biochemical, Cardiorespiratory and Physical Parameters in Sedentary Prediabetic Population
- ClinicalTrials.gov ID
- NCT04949958
- Acronym / sponsor ID
- REC/Lhr/21/1103 Sana Hafeez
- Conditions
- PreDiabetes
- Keywords
- Prediabetic, Exercise intervention, Biochemical parameters, Cardiorespiratory parameters, Physical parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Exercise Based Manual (Supervised) | Experimental | Other: Exercise Based Manual (Supervised)Supervised Exercises with exercise based Manual (exercise \& Educational Component) for 3 days / week for 16 weeks. Each session will comprise of 60 minutes of different type of exercises including warm up and rest interval |
| Experimental: Exercise Based Manual (Home Based) | Experimental | Other: Exercise Based Manual (Home Based)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. |
| Placebo Comparator: Control | Placebo comparator | Other: ControlAge matched Control Group followed for 16 weeks with General Advise to active |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Based Manual (Supervised)Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise, Exercise and Education. The exercise will be supervised while other component will be home based. | Other | Experimental: Exercise Based Manual (Supervised) |
| Exercise Based Manual (Home Based)Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise and Education. All two components will be home based. | Other | Experimental: Exercise Based Manual (Home Based) |
| ControlGeneral advice to be active | Other | Placebo Comparator: Control |
Primary outcome
Hemoglobin A1c Test (HbA1C0
Time frame: 16 week
Hemoglobin A1c Test tells you average level of blood sugar over the past 2 to 3 months.The normal range for the hemoglobin A1c level is between 4% and 5.6% and readings will be taken at baseline,8th week and 16 week.
Fasting blood Glucose(FBG)
Time frame: 16 weeks
This test checks your fasting blood sugar levels. Fasting means after not having anything to eat or drink (except water) for at least 8 hours before the test. Normal value will be less than 100 mg/dl and Prediabetes value 100 mg/dl to 125 mg/dl.Reading will be taken after 8 hour fasting. Readings will be taken at baseline,8th week and 16 week
Homeostasis model assessment of β-cell function(HOMA-β)
Time frame: 16 weeks
The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations.It is calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).Sample will be taken from intravenous blood sample \& readings will be taken at baseline and at 16 weeks.
Homeostatic Model Assessment for Insulin Resistance(HOMA-IR)
Time frame: 16 weeks
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. Healthy Range: 1.0 (0.5-1.4).Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. sample will be taken from intravenous blood sample \& readings will be taken at baseline and at 16 weeks.
low-density lipoproteins(LDL)
Time frame: 16 weeks
low-density lipoproteins sometimes called the "bad" cholesterol Value Less than 100mg/dL is Optimal, value 100-129mg/dL Near optimal/above optimal,Value 130-159 mg/dL Borderline high. Reading will be taken at baseline,8th week and at 16 weeks of intervention.
high-density lipoproteins( HDL)
Time frame: 16 weeks
high-density lipoproteins sometimes called the "good" cholesterol.HDL that falls within the range of 40 to 59 mg/dL is normal. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Triglycerides
Time frame: 16 weeks
Triglycerides are a type of fat (lipid) found in your blood. Normal triglyceride levels in the blood are less than 150 mg per deciliter (mg/dL). Readings will be taken at baseline,8th week and 16 weeks of intervention.
Maximal oxygen consumption( VO2max)
Time frame: 16 weeks
the maximum or optimum rate at which the heart, lungs, and muscles can effectively use oxygen during exercise, used as a way of measuring a person's individual aerobic capacity.A good VO2 max for a male is 42.5-46.4 mL/kg/min, while a good value for a female is 33.0-36.9 mL/kg/min.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Rate of perceived exertion( PRE)
Time frame: 16 weeks
The RPE scale is used to measure the intensity of your exercise. The RPE scale runs from 0 - 10. Readings will be taken at baseline,8th week and 16 weeks of intervention.
Baseline Dyspnea Index(BDI)
Time frame: 16 weeks
Baseline Dyspnea Index (BDI) measures the severity of dyspnea at the baseline Readings will be taken at baseline,8th week and 16 weeks of intervention.
weight in kilograms
Time frame: 16 weeks
Weight (symbolized w ) is a quantity representing the force exerted on a particle or object by an acceleration field, particularly the gravitational field of the Earth at the surface.Readings will be taken at baseline,8th week and 16 weeks of intervention.
Body mass index (BMI)
Time frame: 16 weeks
is a measure of body fat based on height and weight that applies to adult men and women. Below 18.5 is Underweight,18.5-24.9 is Normal,25.0-29.9 is Overweight, 30.0 and Above is Obese. Readings will be taken at baseline,8th week and 16 weeks of intervention.
waist circumference
Time frame: 16 weeks
Waist circumference is the measurement taken around the abdomen at the level of the umbilicus (belly button). For best health, waist should be less than 40 inches around for men, and less than 35 inches for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
waist to hip ratio (WHR)
Time frame: 16 weeks
Waist too hip ratio is a quick measure of fat distribution that may help indicate a person's overall health. A healthy WHR is: 0.9 or less in men. 0.85 or less for women. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of inelastic measuring tape.
Body fat percentage
Time frame: 16 weeks
body fat percentage as just one way to assess and monitor your weight and overall body composition.Men Women Average value for men is18%-24% and foe women is 25%-31%.Value for Obese men is 25% and higher, for obese women is 32% and higher. Readings will be taken at baseline,8th week and 16 weeks of intervention with use of body fat analyzer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 27776003Rowan CP, Riddell MC, Gledhill N, Jamnik VK. Aerobic Exercise Training Modalities and Prediabetes Risk Reduction. Med Sci Sports Exerc. 2017 Mar;49(3):403-412. doi: 10.1249/MSS.0000000000001135.
- Background: PubMed 30064689Williams AN, Konopken YP, Keller CS, Castro FG, Arcoleo KJ, Barraza E, Patrick DL, Olson ML, Shaibi GQ. Corrigendum to 'Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods☆'' [Contemp. Clin. Trials 54 (2017) 68-76]. Contemp Clin Trials. 2018 Aug;71:205. doi: 10.1016/j.cct.2018.06.014. Epub 2018 Jul 7. No abstract available.
- Background: PubMed 24423095Aguiar EJ, Morgan PJ, Collins CE, Plotnikoff RC, Callister R. Efficacy of interventions that include diet, aerobic and resistance training components for type 2 diabetes prevention: a systematic review with meta-analysis. Int J Behav Nutr Phys Act. 2014 Jan 15;11:2. doi: 10.1186/1479-5868-11-2.
- Background: PubMed 23032182Barengo NC, Tuomilehto J. Diabetes: exercise benefits in type 2 diabetes mellitus. Nat Rev Endocrinol. 2012 Nov;8(11):635-6. doi: 10.1038/nrendo.2012.182. Epub 2012 Oct 2. No abstract available.
- Background: PubMed 30273708Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Shakil ur Rehman, PhD study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Based Manual (Supervised) and Exercise Based Manual (Home Based) in people with PreDiabetes, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c Test (HbA1C0 (time frame: 16 week). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949958, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.