Clinical trial NCT04813133: Role of Synchronized Lifestyle Modification Program in Insulin Dependent Diabetic Peripheral Neuropathy Patients
Official title: Role of Synchronized Lifestyle Modification Program in Peripheral Neuropathy in Insulin Dependent Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Synchronized Lifestyle Modification Program
Diabetic Neuropathy
Insulin
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 216
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lifestyle pattern assessment
timeFrame: 12 weeks
measure: Calculation of Body Mass Index
timeFrame: 12 weeks
measure: Measurement of Systolic Blood Pressure
timeFrame: 12 weeks
measure: Measurement of Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Assessment of Presence and Severity of Neuropathy by Michigan Neuropathy Screening Instrument (MNSI)
timeFrame: 12 weeks
measure: Measurement of Peak Latency of Sensory Nerves of lower extremities (Sural and Peroneal)
timeFrame: 12 weeks
measure: Measurement of Amplitude of Sensory Nerves of lower extremities (Sural and Peroneal)
timeFrame: 12 weeks
measure: Velocity of Sensory Nerves of lower extremities (Sural and Peroneal)
timeFrame: 12 weeks
measure: Onset Latency of Motor Nerves (Peroneal and Tibial)
timeFrame: 12 weeks
measure: Amplitude of Motor Nerves (Peroneal and Tibial)
timeFrame: 12 weeks
measure: Velocity of Motor Nerves (Peroneal and Tibial)
timeFrame: 12 weeks
measure: Assessment of Balance by Berg Balance Scale (BBS)
timeFrame: 12 weeks
measure: Fasting Blood Glucose
timeFrame: 12 weeks
measure: Serum HbA1c concentration
timeFrame: 12 weeks
measure: Serum Triglycerides
timeFrame: 12 week
measure: Serum Total Cholesterol
timeFrame: 12 weeks
measure: Serum Low Density Lipoproteins (LDL)
timeFrame: 12 weeks
measure: Serum High Density Lipoproteins (HDL)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Railway Hospital, Islamabad
state: Federal
Study officials:
affiliation: Riphah International University
name: Shazia Ali, PhD
role: PRINCIPAL_INVESTIGATOR
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