Role of Synchronized Lifestyle Modification Program in Insulin Dependent Diabetic Peripheral Neuropathy Patients

NCT04813133 | Completed

• 1 other identifier: IRC/23/233 Tayyaba Anis Ch.
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the role of Synchronized Lifestyle modification program along with Physiotherapy on the symptoms of DPN in patients on insulin therapy.

Conditions

Diabetic Neuropathies

Keywords

Synchronized Lifestyle Modification Program; Diabetic Neuropathy; Insulin

Outcome Measures

Primary Outcomes (18)

• Lifestyle pattern assessment

  Changes from baseline assessed through a self structured questionnaire consisted of open ended questions to assess the timing and type of food taken in meals, daily water intake and sleeping habits. Total 10 questions are included.

  12 weeks

• Calculation of Body Mass Index

  Changes from baseline calculated by measuring height through metal measuring tape in meters and weight in kilograms through potable manual weighing scale. BMI with minimum value of 18.5 and maximum value of 24.5 Kilogram/ square meter. Below 18.5 is considered as underweight and above 24.9 is considered as obese

  12 weeks

• Measurement of Systolic Blood Pressure

  Changes from baseline are assessed by using Mercury Sphygmomanometer with minimum value of 110 millimeter of Mercury and maximum value of 130 millimeter of Mercury. Below 110 millimeter of Mercury is considered as low systolic pressure and above 130 millimeter of Mercury is considered as high systolic pressure

  12 weeks

• Measurement of Diastolic Blood Pressure

  Changes from baseline are assessed by using Mercury Sphygmomanometer with minimum value of 60 millimeter of Mercury and maximum value of 90 millimeter of Mercury. Below 60 millimeter of Mercury is considered as low diastolic pressure and above 90 millimeter of Mercury is considered as high diastolic pressure

  12 weeks

• Assessment of Presence and Severity of Neuropathy by Michigan Neuropathy Screening Instrument (MNSI)

  Changes from baseline are assessed by Michigan Neuropathy Screening Instrument (MNSI) that consists of a history questionnaire comprising of 15 questions related to symptoms of diabetic neuropathy with a score of \>7 is considered as abnormal and Physical examination that consists of inspection of foot for deformities, ulcers and callus formation, Ankle reflex and vibration sensation with a score of \>2.5 is considered abnormal

  12 weeks

• Measurement of Peak Latency of Sensory Nerves of lower extremities (Sural and Peroneal)

  Changes from baseline are assessed by Nerve Conduction Studies with a maximum value of 4.2 millisecond for sural nerve and 6.1 milliseconds for peroneal nerve are considered normal. Values below 4.2 and 6.1 milliseconds are considered abnormal.

  12 weeks

• Measurement of Amplitude of Sensory Nerves of lower extremities (Sural and Peroneal)

  Changes from baseline are assessed by Nerve Conduction Studies with a value of 2 microvolts for peroneal nerve and 6 microvolts for sural nerve are considered normal. Values below 2 and 6 microvolts were considered abnormal.

  12 weeks

• Velocity of Sensory Nerves of lower extremities (Sural and Peroneal)

  Changes from baseline are assessed by Nerve Conduction Studies with minimum limit of 44 meters /second and maximum limit of 64 meters/second. Value below 44m/sec and above 64m/sec are considered abnormal.

  12 weeks

• Onset Latency of Motor Nerves (Peroneal and Tibial)

  Changes from baseline are assessed by Nerve Conduction Studies with a value of 6.1 milliseconds for both nerves is considered normal. Value below 6.1 milliseconds is considered abnormal.

  12 weeks

• Amplitude of Motor Nerves (Peroneal and Tibial)

  Changes from baseline are assessed by Nerve Conduction Studies with a value of 2 millivolts for peroneal nerve and 3 millivolts for tibial nerve is considered normal. Value below 2 and 3 microvolts is considered abnormal.

  12 weeks

• Velocity of Motor Nerves (Peroneal and Tibial)

  Changes from baseline are assessed by Nerve Conduction Studies with a value of 41 m/sec is considered normal. Value below 41 m/sec is considered abnormal

  12 weeks

• Assessment of Balance by Berg Balance Scale (BBS)

  Changes from baseline are assessed by Berg Balance Scale (BBS) with Low Fall Risk score of 41-56, Medium Fall Risk 21-40, High Fall Risk 0-20

  12 weeks

• Fasting Blood Glucose

  Changes from baseline are measured by glucose oxidase strip method in milligram/deciliter using glucometer with a minimum value of 72 mg/dL and a maximum value of 99mg/dL is considered normal. Value below 72mg/dL is considered as hypoglycemia and value above 99 mg/dL is considered hyperglycemia.

  12 weeks

• Serum HbA1c concentration

  Changes from baseline are measured by Ion Exchange Chromatography with a minimum value of 4% and maximum value of 5.9% is considered normal.

  12 weeks

• Serum Triglycerides

  Changes from baseline are measured by Glycerol Phosphate Enzyme Based Method with a minimum value of 150 milligram /deciliter and a maximum value of 199 milligram/deciliter is considered normal. Value above 200 milligram/deciliter is considered as increased serum triglycerides

  12 week

• Serum Total Cholesterol

  Changes from baseline are measured by Cholesterol Oxidase Enzyme Based Method with a minimum value of 125 and a maximum value of 200 milligram /deciliters considered as normal. Value above 200 milligram/deciliter is considered as hypercholesterolemia.

  12 weeks

• Serum Low Density Lipoproteins (LDL)

  Changes from baseline are measured by Friedewald calculation with a minimum value of 100 and a maximum value of 120 milligram /deciliter is considered as normal.

  12 weeks

• Serum High Density Lipoproteins (HDL)

  Changes from baseline are measured by Direct Enzymatic Immuno-inhibition with a maximum value of 40milligram/deciliter and higher is considered as normal. Value below 40 milligram/deciliter is considered as abnormal.

  2 weeks

Study Arms (4)

Synchronized Lifestyle Modification Program

EXPERIMENTAL

Synchronized Lifestyle Modification Program

Other: Synchronized Lifestyle Modification Program

Synchronized Lifestyle Modification Program and Physiotherapy

EXPERIMENTAL

Synchronized Lifestyle Modification Program and Physiotherapy

Other: Synchronized Lifestyle Modification Program and Physiotherapy

Physiotherapy

EXPERIMENTAL

Physiotherapy included Aerobics, Resistance exercise, Flexibility exercise, and Balance exercise.

Other: Physiotherapy

Control Group

NO INTERVENTION

No intervention will be given to this Group

Interventions

Synchronized Lifestyle Modification Program OTHER

Synchronization of dietary intake with circadian rhythm of the body.

Synchronized Lifestyle Modification Program

Synchronized Lifestyle Modification Program and Physiotherapy OTHER

Synchronization of dietary intake with circadian rhythm of the body along with Physiotherapy ( Aerobics, flexibility, resistance and balance exercises.)

Synchronized Lifestyle Modification Program and Physiotherapy

Physiotherapy OTHER

Only Physiotherapy training which includes ( Aerobics, flexibility, resistance and balance exercises.)

Physiotherapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both males and females
• Five years duration of clinically diagnosed type 2 Diabetes were included in the study
• On insulin therapy
• Diagnosed to have peripheral neuropathy according to Michigan Neuropathy Screening Instrument with a physical examination score \> 2.5

You may not qualify if:

• Type 1 Diabetics
• Type 2 Diabetics
• On oral hypoglycemic and Glucagon-like Peptide-1 analogues, patients having neuropathies due to other causes (Vitamin B₁₂ deficiency, Drug and Alcohol abuse), patients with other co-morbidities (Renal insufficiency, Heart, Liver and Eye diseases)
• Patients with foot ulcers and orthopedic or surgical problems of lower limb
• Patients with peripheral vascular diseases, inability to walk independently
• Patients receiving any structured supervised physiotherapy intervention
• Pregnant females were excluded from the study

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital, Islamabad

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (15)

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  PMID: 26781070 BACKGROUND

• Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, Sheikh A, Raza A, Fazid S, Jadoon Z, Ishtiaq O, Safdar N, Afridi H, Heald AH. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019 Feb 21;9(2):e025300. doi: 10.1136/bmjopen-2018-025300.

  PMID: 30796126 BACKGROUND

• Diabetes DOF. DEFINITION AND DESCRIPTION OF DIABETES OTHER CATEGORIES OF GLUCOSE. 2010;33.

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• Lilly E, Homburg B. P R O G R E S S I O N , Initiating Insulin Therapy in Type 2. 2009;32:0-5.

  BACKGROUND

• Majeedkutty NA, Jabbar MA. Physical Therapy for Diabetic Peripheral Neuropathy : A Narrative Review. 30(1):112-25.

  BACKGROUND

• Alam U, Riley DR, Jugdey RS, Azmi S, Rajbhandari S, D'Aout K, Malik RA. Diabetic Neuropathy and Gait: A Review. Diabetes Ther. 2017 Dec;8(6):1253-1264. doi: 10.1007/s13300-017-0295-y. Epub 2017 Sep 1.

  PMID: 28864841 BACKGROUND

• Papanas N, Ziegler D. Risk Factors and Comorbidities in Diabetic Neuropathy: An Update 2015. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):48-62. doi: 10.1900/RDS.2015.12.48. Epub 2015 Aug 10.

  PMID: 26676661 BACKGROUND

• Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.

  PMID: 27445060 BACKGROUND

• Education DS. 4 . Lifestyle Management. 2017;40(January):33-43.

  BACKGROUND

• Nadi M, Marandi SM, Esfarjani F, Saleki M, Mohammadi M. The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women. Adv Biomed Res. 2017 May 2;6:55. doi: 10.4103/2277-9175.205528. eCollection 2017.

  PMID: 28553628 BACKGROUND

• Handsaker JC, Brown SJ, Bowling FL, Maganaris CN, Boulton AJ, Reeves ND. Resistance exercise training increases lower limb speed of strength generation during stair ascent and descent in people with diabetic peripheral neuropathy. Diabet Med. 2016 Jan;33(1):97-104. doi: 10.1111/dme.12841. Epub 2015 Jul 17.

  PMID: 26108438 BACKGROUND

• Andayani TM, Izham M, Ibrahim M, Asdie AH. Comparison of the glycemic control of insulin and triple oral therapy in type 2 diabetes mellitus. 2010;1(April):13-8.

  BACKGROUND

• Rahimi N, Samavati Sharif MA, Goharian AR, Pour AH. The Effects of Aerobic Exercises and 25(OH) D Supplementation on GLP1 and DPP4 Level in Type II Diabetic Patients. Int J Prev Med. 2017 Aug 8;8:56. doi: 10.4103/ijpvm.IJPVM_161_17. eCollection 2017.

  PMID: 28900535 BACKGROUND

• DE BODO RC, ALTSZULER N, DUNN A, STEELE R, ARMSTRONG DT, BISHOP JS. Effects of exogenous and endogenous insulin on glucose utilization and production. Ann N Y Acad Sci. 1959 Sep 25;82:431-51. doi: 10.1111/j.1749-6632.1959.tb44924.x. No abstract available.

  PMID: 13814676 BACKGROUND

• Donnor T, Sarkar S. Insulin- Pharmacology, Therapeutic Regimens and Principles of Intensive Insulin Therapy. 2023 Feb 15. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK278938/

  PMID: 25905175 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Insulin Resistance

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Shazia Ali, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 24, 2021
• Study Start: February 5, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)