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

NCT ID: NCT04813133

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2022-01-30

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.

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.

Conditions

Diabetic Neuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synchronized Lifestyle Modification Program

Synchronized Lifestyle Modification Program

Group Type: EXPERIMENTAL

Synchronized Lifestyle Modification Program

Intervention Type: OTHER

Synchronization of dietary intake with circadian rhythm of the body.

Synchronized Lifestyle Modification Program and Physiotherapy

Synchronized Lifestyle Modification Program and Physiotherapy

Group Type: EXPERIMENTAL

Synchronized Lifestyle Modification Program and Physiotherapy

Intervention Type: OTHER

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

Physiotherapy

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

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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

Control Group

No intervention will be given to this Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.)

Intervention Type: OTHER

Physiotherapy

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

Intervention Type: OTHER

Synchronized Lifestyle Modification Program

Synchronization of dietary intake with circadian rhythm of the body.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shazia Ali, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Pakistan Railway Hospital, Islamabad

Islamabad, Federal, Pakistan

Countries

Pakistan

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Other Identifiers

IRC/23/233 Tayyaba Anis Ch.

Identifier Type: -

Identifier Source: org_study_id