Effects of Exercise Based Manual in Sedentary Prediabetic Population

NCT04949958 | Completed

• 1 other identifier: REC/Lhr/21/1103 Sana Hafeez
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

PreDiabetes

Keywords

Prediabetic; Exercise intervention; Biochemical parameters; Cardiorespiratory parameters; Physical parameters

Outcome Measures

Primary Outcomes (15)

• 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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  16 weeks

Study Arms (3)

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

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.

Other: Exercise Based Manual (Home Based)

Placebo Comparator: Control

PLACEBO COMPARATOR

Age matched Control Group followed for 16 weeks with General Advise to active

Other: Control

Interventions

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.

Experimental: Exercise Based Manual (Supervised)

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.

Experimental: Exercise Based Manual (Home Based)

Control OTHER

General advice to be active

Placebo Comparator: Control

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabiliation Center

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 27776003 BACKGROUND

• Williams 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.

  PMID: 30064689 BACKGROUND

• Aguiar 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.

  PMID: 24423095 BACKGROUND

• Barengo 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.

  PMID: 23032182 BACKGROUND

• Rhodes 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.

  PMID: 30273708 BACKGROUND

• Jensen 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.

  PMID: 24239920 BACKGROUND

• Kosaka 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.

  PMID: 15649575 BACKGROUND

• Pan 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.

  PMID: 9096977 BACKGROUND

• American 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.

  PMID: 22187469 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Syed Shakil ur Rehman, PhD

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple Blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 2, 2021
• Study Start: April 15, 2022
• Primary Completion: October 25, 2023
• Study Completion: November 20, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)