Clinical trial NCT04813146: Role of Synchronized Lifestyle Modification Program on Diabetic Neuropathy Taking Oral Hypoglycemics
Official title: Role of Synchronized Lifestyle Modification Program on Diabetic Peripheral Neuropathy Patients Taking Oral Hypoglycemics and GLP-1 Analogues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Synchronized Lifestyle Modification Program
Diabetic Neuropathy
Oral Hypoglycemic Agents
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: 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.

Eligibility criteria: 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)

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

Primary outcomes:
measure: Life style 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: Michigan Neuropathy Screening Instrument
timeFrame: 12 weeks
measure: Peak latency of Sensory Nerves (Sural and Peroneal)
timeFrame: 12 weeks
measure: Amplitude of Sensory Nerves (Sural and Peroneal)
timeFrame: 12 weeks
measure: Velocity of Sensory Nerves
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
timeFrame: 12 weeks
measure: Serum Fasting Blood Glucose
timeFrame: 12 weeks
measure: Serum Total Cholesterol
timeFrame: 12 weeks
measure: Serum Triglycerides
timeFrame: 12 weeks
measure: Serum High Density Lipoproteins (HDL)
timeFrame: 12 weeks
measure: Serum Low Density Lipoproteins
timeFrame: 12 weeks
measure: Serum HbA1c concentration
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Railway Hospital
state: Federal
Study officials:
affiliation: Riphah International University
name: Shazia Ali, PhD
role: PRINCIPAL_INVESTIGATOR
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