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

Not Applicable

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Other: SLP along with Physiotherapy; Other: SLP; Other: Physiotherapy

• Registration Number: NCT04813146
• Lead Sponsor: Riphah International University

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.

Detailed Description

Diabetes mellitus (DM) is a chronic metabolic disease defined by persistently increased blood glucose levels with fasting blood glucose ≥ 126 mg/dl, random plasma glucose ≥ 200mg/dl and HbA1c ≥ 6.5%.

Diabetes has emerged as a great socioeconomic burden for the developing world. In 2017, globally, 451 million people were affected with diabetes. In Pakistan, the prevalence of type 2 diabetes is 16.98% which differs significantly with age, education, body mass index (BMI), obesity, family history and blood pressure. DM is classified into type 1 diabetes (T1D) and type 2 diabetes (T2D). T1D occurs due to an autoimmune pancreatic beta cell destruction with consequent insulin deficiency whereas T2D occurs due to predominantly insulin resistance with relative insulin deficiency or defective secretion. T2D cause serious and chronic microvascular and macrovascular complications. One of the most prevalent microvascular complication is diabetic peripheral neuropathy (DPN). DPN is defined as distal, symmetric sensorimotor polyneuropathy as a result of hyperglycemia and microangiopathy. It is a demyelinating disease of peripheral nerve fibers that manifests as parasthesias, impairment of sensations of vibration, proprioception, touch, pressure, pain and temperature.

Risk factors of DPN are age, duration of diabetes, HbA1c \>7.0%, increased BMI, hyperlipidemia and hyperglycemia. Treatment of T2D is targeted towards good glycemic control that includes life style modifications i.e. diet and exercise, oral hypoglycemic agents (OHAs) and subcutaneous insulin administration. In life style modification, variety of exercises are recommended that help to slow the progression of peripheral neuropathy.These include; aerobic training, weight-bearing, static and dynamic balance training and strength training exercises which improve the gait speed, stride length and nerve conduction velocities (NCVs) of sensory and motor nerves while flexibility exercises improve the range-of-motion in ankle, hip and shoulder joints and keep them flexible. Importance of dietary modification is enhanced if it is synchronized with the circadian rhythm of the body. Therefore, Synchronized Lifestyle Modification Program (SLP) is a personalized, homeostasis restoring, liver centric lifestyle modification program that works through the correction of body clock rhythm. Lifestyle medicine is defined as the discipline of studying how daily habits and practices impact both on the prevention and treatment of disease. Its key aspects are: regular physical activity, proper nutrition, weight management, avoiding tobacco and a sound mental health. Lifestyle modification in diabetics is believed to enhance the function of pancreatic islet cells and induce glucose-stimulated insulin release.Regarding pharmacological treatment, following OHAs are used which are; biguanides, insulin secretagogues, alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors and sodium glucose co-transporter-2 inhibitors. Now a days, an injectable agent i.e. Glucagon like peptide-1(GLP-1) receptor agonist is used with OHAs and is effective in decreasing blood glucose levels with a low risk of hypoglycemia in elderly patients.

Limited data is available which supports the combined effect of Synchronized Lifestyle modification Program (SLP) and Physiotherapy in the progression of DPN in T2D patients taking OHAs and GLP-1.

Study Timeline

• Study First Submitted: 2021-02-02
• Study Start: 2021-02-05
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-24
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synchronized Lifestyle Modification Program along with Physiotherapy	SLP along with Physiotherapy	Synchronized Lifestyle Modification Program along with Physiotherapy (Synchronization of dietary intake and Physiotherapy including aerobic, resistance, flexibility and balance exercises)
Synchronized Lifestyle Modification Program (SLP)	SLP	Synchronized Lifestyle Modification Program ( Synchronization of dietary intake with the natural circadian rhythm of the body)
Physiotherapy	Physiotherapy	Physiotherapy (aerobics, resistance, flexibility and balance exercises)

Primary Outcome Measures

Name	Time	Method
Life style pattern assessment	12 weeks	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.
Michigan Neuropathy Screening Instrument	12 weeks	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.
Serum Fasting Blood Glucose	12 weeks	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.
Serum Total Cholesterol	12 weeks	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).
Serum High Density Lipoproteins (HDL)	12 weeks	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).
Measurement of Systolic Blood pressure	12 weeks	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.
Measurement of Diastolic Blood pressure	12 weeks	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.
Onset Latency of Motor Nerves (Peroneal and Tibial)	12 weeks	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.
Calculation of Body Mass Index	12 weeks	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.
Velocity of Sensory Nerves	12 weeks	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.
Serum Triglycerides	12 weeks	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).
Serum HbA1c concentration	12 weeks	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.
Peak latency of Sensory Nerves (Sural and Peroneal)	12 weeks	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.
Amplitude of Sensory Nerves (Sural and Peroneal)	12 weeks	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.
Amplitude of Motor Nerves (Peroneal and Tibial)	12 weeks	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.
Velocity of Motor Nerves (Peroneal and Tibial)	12 weeks	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.
Assessment of Balance by Berg Balance Scale	12 weeks	Changes from baseline are assessed with Low Fall Risk 41-56, Medium Fall Risk 21-40, High Fall Risk 0-20.
Serum Low Density Lipoproteins	12 weeks	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).

Trial Locations

Locations (1)

Pakistan Railway Hospital; 🇵🇰 Islamabad, Federal, Pakistan