Role of Synchronized Lifestyle Modification Program on Diabetic Neuropathy Taking Oral Hypoglycemics

NCT04813146 | Completed

• 1 other identifier: IRC/20/234 Rubab Rameez
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the combined effect of SLP along with Physiotherapy in improving Type 2 DPN patients taking OHAs and GLP-1 analogues.

Conditions

Diabetic Neuropathies

Keywords

Synchronized Lifestyle Modification Program; Diabetic Neuropathy; Oral Hypoglycemic Agents

Outcome Measures

Primary Outcomes (18)

• Life style pattern assessment

  Changes from baseline, assessed through a self-structured questionnaire consisting 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 in meters through a metal measuring tape and weight in kilograms through portable manual weighing scale. BMI with minimum value of 18.5 kilogram/ meters square (kg/m2) and maximum value of 24.9 kilogram /meters square (kg/m2). Below 18.5 kilograms/meters square (kg/m2) is considered as underweight and above 24.9 kilogram/meters square (kg/m2) 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 (mmHg) and the maximum value of 130 millimeter of mercury (mmHg). Below 110 millimeter of mercury (mmHg) is considered as low systolic blood pressure and above 130 millimeter of mercury (mmHg) is considered as high systolic blood 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 (mmHg) and the maximum value of 90 millimeter of mercury (mmHg). Below 60 millimeter of mercury (mmHg) is considered as low diastolic blood pressure and a value above 90 millimeter of mercury (mmHg) is considered as high diastolic blood pressure.

  12 weeks

• Michigan Neuropathy Screening Instrument

  Changes from baseline is assessed. Subjective assessment is done by a questionnaire that is self-administered by the participants. Responses of "yes" are given to questions 1-3, 5-6, 8-9, 11-12, 14-15 and each of them counted as one point. A "no" response is given on questions 7 and 13 and are counted as 1 point. A score of more than or equal to 7 in the history questionnaire is considered abnormal. Lower extremity examination includes inspection and assessment of vibratory sensation and ankle reflexes which is considered as abnormal at a score of more than or equal to 2.5.

  12 weeks

• Peak latency of Sensory Nerves (Sural and Peroneal)

  Changes from baseline is assessed through nerve conduction studies. Value of 4.2 millisecond (ms) of sural nerve and 6.1 millisecond (ms) for peroneal nerve is considered normal. Values below 4.2 millisecond (ms) and 6.1 millisecond (ms) are considered abnormal.

  12 weeks

• Amplitude of Sensory Nerves (Sural and Peroneal)

  Changes from baseline are assessed through nerve conduction studies with a value of 6 microvolt (µV) for sural nerve and 2 microvolt (µV) for peroneal are considered normal. Values below 6 microvolt (µV) and 2 microvolt (µV) are considered abnormal.

  12 weeks

• Velocity of Sensory Nerves

  Changes from baseline are assessed through nerve conduction studies with value of 41 meters/second (m/sec) is considered normal. Value below 41meters/second (m/sec) is considered abnormal.

  12 weeks

• Onset Latency of Motor Nerves (Peroneal and Tibial)

  Changes from baseline are assessed through nerve conduction studies with value of 6.1 millisecond (ms) for both are considered normal. Value below 6.1 millisecond (ms) is considered abnormal.

  12 weeks

• Amplitude of Motor Nerves (Peroneal and Tibial)

  Changes from baseline are assessed through nerve conduction studies with values of 2 millivolt (mV) and 3 millivolt (mV) are considered normal. Values below 2 millivolt (mV) and 3 millivolt (mV) are considered abnormal.

  12 weeks

• Velocity of Motor Nerves (Peroneal and Tibial)

  Changes from baseline are assessed through nerve conduction studies with values of 41 meters/second (m/sec) is considered normal for both nerves. Value less than 41 meters/second (m/sec) is considered abnormal.

  12 weeks

• Assessment of Balance by Berg Balance Scale

  Changes from baseline are assessed with Low Fall Risk 41-56, Medium Fall Risk 21-40, High Fall Risk 0-20.

  12 weeks

• Serum Fasting Blood Glucose

  Changes from baseline are measured by Glucose oxidase enzyme based method in milligram/deciliter (mg/dL) using Glucometer with minimum value of 72 milligram/deciliter (mg/dL) and maximum value of 99 milligram/deciliter (mg/dL). Value below 72 milligram/deciliter (mg/dL) is considered hypoglycemic and above 99 milligram/deciliter (mg/dL) is hyperglycemic.

  12 weeks

• Serum Total Cholesterol

  Changes from baseline are measured by Cholesterol oxidase enzyme based method with minimum value of 125 milligram/deciliter (mg/dL) and maximum value of 200 milligram/deciliter (mg/dL).

  12 weeks

• Serum Triglycerides

  Changes from baseline are measured by Glycerol phosphate enzyme based method with minimum value of less than150 milligram/deciliter (mg/dL) and maximum value of199 milligram/deciliter (mg/dL).

  12 weeks

• Serum High Density Lipoproteins (HDL)

  Changes from baseline are measured by Direct enzymatic immune-inhibition with minimum value of 40 milligram/deciliter (mg/dL) and maximum value of greater than 40 milligram/deciliter (mg/dL).

  12 weeks

• Serum Low Density Lipoproteins

  Changes from baseline are measured by Friedewald calculation with minimum value of 100 milligram/deciliter (mg/dL) and maximum value of 129 milligram/deciliter (mg/dL).

  12 weeks

• Serum HbA1c concentration

  Changes from baseline are measured by Ion exchange chromatography with minimum value of 4 % and maximum value of 5.9 %. Normal range for the HbA1c level is between 4% and 5.6%. Levels between 5.7% and 6.4% is the pre-diabetic range. Levels of 6.5% or higher is diabetic range.

  12 weeks

Study Arms (4)

Synchronized Lifestyle Modification Program (SLP)

EXPERIMENTAL

Synchronized Lifestyle Modification Program ( Synchronization of dietary intake with the natural circadian rhythm of the body)

Other: SLP

Synchronized Lifestyle Modification Program along with Physiotherapy

EXPERIMENTAL

Synchronized Lifestyle Modification Program along with Physiotherapy (Synchronization of dietary intake and Physiotherapy including aerobic, resistance, flexibility and balance exercises)

Other: SLP along with Physiotherapy

Physiotherapy

EXPERIMENTAL

Physiotherapy (aerobics, resistance, flexibility and balance exercises)

Other: Physiotherapy

Control Group

NO INTERVENTION

No Intervention will be given to this group ( conventional medicine will be given to these patient )

Interventions

SLP OTHER

Synchronization of dietary intake with circadian rhythm of the body

Synchronized Lifestyle Modification Program (SLP)

SLP along with Physiotherapy OTHER

Synchronization of dietary intake along with Physiotherapy (aerobic, flexibility, resistance and balance exercises)

Synchronized Lifestyle Modification Program along with Physiotherapy

Physiotherapy OTHER

Physiotherapy given only (aerobic, 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:

• Gender includes both male and female
• Patients between age group 40-75 years
• Clinically diagnosed patients of Type 2 diabetes on OHAs and GLP-1 analogues
• Diabetic patients with symptomatic peripheral neuropathy (Severity of DPN is associated with a physical examination score \> 2.5 by using Michigan Neuropathy Screening Instrument (MNSI) with grades mild, moderate and severe)

You may not qualify if:

• Type 1 diabetic patients
• Age \< 40 years and \> 75 years
• Patients with any other co-morbidities (Heart, liver and kidney diseases)
• Patients with neuropathies due to any other disease
• Orthopaedic and surgical procedure of lower limbs
• Patients with foot ulcers
• Peripheral vascular diseases
• Patients receiving any structured supervised physiotherapy
• Pregnant females

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (13)

• Khawandanah J. Double or hybrid diabetes: A systematic review on disease prevalence, characteristics and risk factors. Nutr Diabetes. 2019 Nov 4;9(1):33. doi: 10.1038/s41387-019-0101-1.

  PMID: 31685799 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 Canada Clinical Practice Guidelines Expert Committee; Punthakee Z, Goldenberg R, Katz P. Definition, Classification and Diagnosis of Diabetes, Prediabetes and Metabolic Syndrome. Can J Diabetes. 2018 Apr;42 Suppl 1:S10-S15. doi: 10.1016/j.jcjd.2017.10.003. No abstract available.

  PMID: 29650080 BACKGROUND

• Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.

  PMID: 29709457 BACKGROUND

• Cancelliere P. A Review of the Pathophysiology and Clinical Sequelae of Diabetic Polyneuropathy in the Feet. J Diabetes, Metab Disord Control. 2016;3(2):21-4.

  BACKGROUND

• Liu X, Xu Y, An M, Zeng Q. The risk factors for diabetic peripheral neuropathy: A meta-analysis. PLoS One. 2019 Feb 20;14(2):e0212574. doi: 10.1371/journal.pone.0212574. eCollection 2019.

  PMID: 30785930 BACKGROUND

• Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Horwitch C, Kansagara D, McLean RM, Wilt TJ. Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline Update From the American College of Physicians. Ann Intern Med. 2017 Feb 21;166(4):279-290. doi: 10.7326/M16-1860. Epub 2017 Jan 3.

  PMID: 28055075 BACKGROUND

• Gholami F, Nikookheslat S, Salekzamani Y, Boule N, Jafari A. Effect of aerobic training on nerve conduction in men with type 2 diabetes and peripheral neuropathy: A randomized controlled trial. Neurophysiol Clin. 2018 Sep;48(4):195-202. doi: 10.1016/j.neucli.2018.03.001. Epub 2018 Mar 30.

  PMID: 29606547 BACKGROUND

• Majeedkutty NA, Jabbar MA, Sreenivasulu S. Physical therapy for diabetic peripheral neuropathy: A narrative review. Disabil CBR Incl Dev. 2019;30(1):112-25.

  BACKGROUND

• Bae SA, Fang MZ, Rustgi V, Zarbl H, Androulakis IP. At the Interface of Lifestyle, Behavior, and Circadian Rhythms: Metabolic Implications. Front Nutr. 2019 Aug 28;6:132. doi: 10.3389/fnut.2019.00132. eCollection 2019.

  PMID: 31555652 BACKGROUND

• Parr EB, Heilbronn LK, Hawley JA. A Time to Eat and a Time to Exercise. Exerc Sport Sci Rev. 2020 Jan;48(1):4-10. doi: 10.1249/JES.0000000000000207.

  PMID: 31688298 BACKGROUND

• Rippe JM. Lifestyle Medicine: The Health Promoting Power of Daily Habits and Practices. Am J Lifestyle Med. 2018 Jul 20;12(6):499-512. doi: 10.1177/1559827618785554. eCollection 2018 Nov-Dec.

  PMID: 30783405 BACKGROUND

• Marin-Penalver JJ, Martin-Timon I, Sevillano-Collantes C, Del Canizo-Gomez FJ. Update on the treatment of type 2 diabetes mellitus. World J Diabetes. 2016 Sep 15;7(17):354-95. doi: 10.4239/wjd.v7.i17.354.

  PMID: 27660695 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System 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)