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

November 19, 2024 updated by: Riphah International University

Role of Synchronized Lifestyle Modification Program in Peripheral Neuropathy in Insulin Dependent Type 2 Diabetics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetes mellitus (DM) is a metabolic disorder which influence about 8.3% of adult population and is the fifth major cause of death globally. In Pakistan, prevalence of type 2 diabetes is 16.98% according to recent survey held in 2019. DM is classified into type 1 and type 2 diabetes. In type 1 diabetes, there is an absolute deficiency of insulin secretion due to an autoimmune pathologic process occurring in beta islets of pancreas. While Type 2 diabetes is characterized by a combination of insulin resistance and inadequate insulin secretion with resultant hyperglycemia leading to micro and macrovascular complications. Macrovascular complications include cardiovascular disease, stroke and peripheral artery disease. Amongst microvascular complications, Diabetic peripheral neuropathy (DPN) is one of the most common complication in both developed and developing countries. DPN is a symmetrical, length-dependent sensorimotor polyneuropathy which is attributed to metabolic and micro vessel alterations due to hyperglycemia and concomitant cardiovascular risk covariates. Major risk factors for development of DPN include duration of diabetes, hyperglycemia, and age, followed by prediabetes, hypertension, dyslipidemia, and obesity. DPN can engender disablement in touch sensation, vibration sense, lower limb proprioception, and kinesthesia thus contributing to impaired balance, altered gait with increased risk of falling. DPN occurs in more than 50% of people with type 2 diabetes. It is a salient risk factor for skin breakdown, amputation, and reduced physical mobility consequently lowering the quality of life Management of DPN is multifaceted and includes efforts to alter the natural history (lifestyle changes) and symptomatic treatments through pharmacological interventions. Daily habits and actions exert an enormous influence on short-term and long-term health and quality of life. Importance of dietary modification is enhanced if it is synchronized with the circadian rhythm of the body. Therefore, Synchronized Lifestyle modification program is a personalized, homeostasis restoring, liver centric lifestyle modification program that works through the correction of body clock rhythm. Lifestyle medicine comprises of cluster of positive lifestyle practices including maintenance of a healthy body weight, regular physical activity, cessation of cigarette smoking, stress reduction as well following a few nutritional practices such as increasing whole grains and consuming more fruits and vegetables. Lifestyle modification, including diet and exercise, slow the progression of neuropathy by promoting small nerve fiber regeneration. Dietary modifications include intake of nutrient, such as whole grains, vegetables, fruits, legumes, low-fat dairy, lean meats, nuts, and seeds. These foods help to maintain body weight, attain individualized glycemic, blood pressure, and lipid goals and prevent complications of diabetes. Exercise improves three of the biggest risk factors for diabetic neuropathy including insulin sensitivity and glucose control, obesity, and dyslipidemia. These exercises include aerobic exercise that improves glycemic control and insulin sensitivity in diabetics. Strength training exercise improves postural sway during standing, and gait characteristics during level-ground walking. While the flexibility exercise are suggested for refining distal joint mobility and plantar pressure distribution during gait. Thus, Exercise is known to enhance multiple metabolic factors that may affect nerve health and microvascular function, which may indirectly protect against peripheral nerve damage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Pakistan Railway Hospital, Islamabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 1 Diabetics
  2. Type 2 Diabetics
  3. 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)
  4. Patients with foot ulcers and orthopedic or surgical problems of lower limb
  5. Patients with peripheral vascular diseases, inability to walk independently
  6. Patients receiving any structured supervised physiotherapy intervention
  7. Pregnant females were excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Synchronized Lifestyle Modification Program
Other: Synchronized Lifestyle Modification Program
Synchronization of dietary intake with circadian rhythm of the body.
Experimental: Synchronized Lifestyle Modification Program and Physiotherapy
Other: Synchronized Lifestyle Modification Program and Physiotherapy
Synchronization of dietary intake with circadian rhythm of the body along with Physiotherapy ( Aerobics, flexibility, resistance and balance exercises.)
Experimental: Physiotherapy
Physiotherapy included Aerobics, Resistance exercise, Flexibility exercise, and Balance exercise.
Other: Physiotherapy
Only Physiotherapy training which includes ( Aerobics, flexibility, resistance and balance exercises.)
No Intervention: Control Group
No intervention will be given to this Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lifestyle pattern assessment
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 week
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
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shazia Ali, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRC/23/233 Tayyaba Anis Ch.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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