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

R

Riphah International University

Status

Completed

Conditions

Diabetic Neuropathies

Treatments

Other: Physiotherapy
Other: Synchronized Lifestyle Modification Program
Other: Synchronized Lifestyle Modification Program and Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04813133
IRC/23/233 Tayyaba Anis Ch.

Details and patient eligibility

About

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.

Full 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.

Enrollment

216 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

216 participants in 4 patient groups

Synchronized Lifestyle Modification Program
Experimental group
Description:
Synchronized Lifestyle Modification Program
Treatment:
Other: Synchronized Lifestyle Modification Program
Synchronized Lifestyle Modification Program and Physiotherapy
Experimental group
Description:
Synchronized Lifestyle Modification Program and Physiotherapy
Treatment:
Other: Synchronized Lifestyle Modification Program and Physiotherapy
Physiotherapy
Experimental group
Description:
Physiotherapy included Aerobics, Resistance exercise, Flexibility exercise, and Balance exercise.
Treatment:
Other: Physiotherapy
Control Group
No Intervention group
Description:
No intervention will be given to this Group

Trial contacts and locations

1

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Central trial contact

Imran Amjad, PhD

Data sourced from clinicaltrials.gov

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