Diabetic NeuropathiesNCT04813133
Role of Synchronized Lifestyle Modification Program in Insulin Dependent Diabetic Peripheral Neuropathy Patients
A study testing Synchronized Lifestyle Modification Program, Synchronized Lifestyle Modification Program and Physiotherapy and Physiotherapy in people with Diabetic Neuropathies, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Synchronized Lifestyle Modification Program, Synchronized Lifestyle Modification Program and Physiotherapy and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Feb 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females
- Five years duration of clinically diagnosed type 2 Diabetes were included in the study
- On insulin therapy
- Diagnosed to have peripheral neuropathy according to Michigan Neuropathy Screening Instrument with a physical examination score > 2.5
Who cannot join
- Type 1 Diabetics
- Type 2 Diabetics
- 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)
- Patients with foot ulcers and orthopedic or surgical problems of lower limb
- Patients with peripheral vascular diseases, inability to walk independently
- Patients receiving any structured supervised physiotherapy intervention
- Pregnant females were excluded from the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway Hospital, Islamabad
Islamabad, Federal, 44000
About this study
Official title: Role of Synchronized Lifestyle Modification Program in Peripheral Neuropathy in Insulin Dependent Type 2 Diabetics
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.
Read the 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
- Being tested
- Synchronized Lifestyle Modification Program, Synchronized Lifestyle Modification Program and Physiotherapy, Physiotherapy
- Keywords
- Synchronized Lifestyle Modification Program, Diabetic Neuropathy, Insulin
- Medical subject headings
- Diabetic Neuropathies, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronized Lifestyle Modification ProgramOther
Synchronization of dietary intake with circadian rhythm of the body.
Synchronized Lifestyle Modification Program and PhysiotherapyOther
Synchronization of dietary intake with circadian rhythm of the body along with Physiotherapy ( Aerobics, flexibility, resistance and balance exercises.)
PhysiotherapyOther
Only Physiotherapy training which includes ( Aerobics, flexibility, resistance and balance exercises.)
| Study group | Role | What they receive |
|---|---|---|
| Synchronized Lifestyle Modification Program | Experimental | Synchronized Lifestyle Modification Program Receives: Other: Synchronized Lifestyle Modification Program |
| Synchronized Lifestyle Modification Program and Physiotherapy | Experimental | Synchronized Lifestyle Modification Program and Physiotherapy Receives: Other: Synchronized Lifestyle Modification Program and Physiotherapy |
| Physiotherapy | Experimental | Physiotherapy included Aerobics, Resistance exercise, Flexibility exercise, and Balance exercise. Receives: Other: Physiotherapy |
| Control Group | No intervention | No intervention will be given to this Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle pattern assessment
Changes from baseline assessed through a self structured questionnaire consisted 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.
Measured: 12 weeks
Calculation of Body Mass Index
Changes from baseline calculated by measuring height through metal measuring tape in meters and weight in kilograms through potable manual weighing scale. BMI with minimum value of 18.5 and maximum value of 24.5 Kilogram/ square meter. Below 18.5 is considered as underweight and above 24.9 is considered as obese
Measured: 12 weeks
Measurement of Systolic Blood Pressure
Changes from baseline are assessed by using Mercury Sphygmomanometer with minimum value of 110 millimeter of Mercury and maximum value of 130 millimeter of Mercury. Below 110 millimeter of Mercury is considered as low systolic pressure and above 130 millimeter of Mercury is considered as high systolic pressure
Measured: 12 weeks
Measurement of Diastolic Blood Pressure
Changes from baseline are assessed by using Mercury Sphygmomanometer with minimum value of 60 millimeter of Mercury and maximum value of 90 millimeter of Mercury. Below 60 millimeter of Mercury is considered as low diastolic pressure and above 90 millimeter of Mercury is considered as high diastolic pressure
Measured: 12 weeks
Assessment of Presence and Severity of Neuropathy by Michigan Neuropathy Screening Instrument (MNSI)
Changes from baseline are assessed by Michigan Neuropathy Screening Instrument (MNSI) that consists of a history questionnaire comprising of 15 questions related to symptoms of diabetic neuropathy with a score of >7 is considered as abnormal and Physical examination that consists of inspection of foot for deformities, ulcers and callus formation, Ankle reflex and vibration sensation with a score of >2.5 is considered abnormal
Measured: 12 weeks
Measurement of Peak Latency of Sensory Nerves of lower extremities (Sural and Peroneal)
Changes from baseline are assessed by Nerve Conduction Studies with a maximum value of 4.2 millisecond for sural nerve and 6.1 milliseconds for peroneal nerve are considered normal. Values below 4.2 and 6.1 milliseconds are considered abnormal.
Measured: 12 weeks
Measurement of Amplitude of Sensory Nerves of lower extremities (Sural and Peroneal)
Changes from baseline are assessed by Nerve Conduction Studies with a value of 2 microvolts for peroneal nerve and 6 microvolts for sural nerve are considered normal. Values below 2 and 6 microvolts were considered abnormal.
Measured: 12 weeks
Velocity of Sensory Nerves of lower extremities (Sural and Peroneal)
Changes from baseline are assessed by Nerve Conduction Studies with minimum limit of 44 meters /second and maximum limit of 64 meters/second. Value below 44m/sec and above 64m/sec are considered abnormal.
Measured: 12 weeks
Onset Latency of Motor Nerves (Peroneal and Tibial)
Changes from baseline are assessed by Nerve Conduction Studies with a value of 6.1 milliseconds for both nerves is considered normal. Value below 6.1 milliseconds is considered abnormal.
Measured: 12 weeks
Amplitude of Motor Nerves (Peroneal and Tibial)
Changes from baseline are assessed by Nerve Conduction Studies with a value of 2 millivolts for peroneal nerve and 3 millivolts for tibial nerve is considered normal. Value below 2 and 3 microvolts is considered abnormal.
Measured: 12 weeks
Velocity of Motor Nerves (Peroneal and Tibial)
Changes from baseline are assessed by Nerve Conduction Studies with a value of 41 m/sec is considered normal. Value below 41 m/sec is considered abnormal
Measured: 12 weeks
Assessment of Balance by Berg Balance Scale (BBS)
Changes from baseline are assessed by Berg Balance Scale (BBS) with Low Fall Risk score of 41-56, Medium Fall Risk 21-40, High Fall Risk 0-20
Measured: 12 weeks
Fasting Blood Glucose
Changes from baseline are measured by glucose oxidase strip method in milligram/deciliter using glucometer with a minimum value of 72 mg/dL and a maximum value of 99mg/dL is considered normal. Value below 72mg/dL is considered as hypoglycemia and value above 99 mg/dL is considered hyperglycemia.
Measured: 12 weeks
Serum HbA1c concentration
Changes from baseline are measured by Ion Exchange Chromatography with a minimum value of 4% and maximum value of 5.9% is considered normal.
Measured: 12 weeks
Serum Triglycerides
Changes from baseline are measured by Glycerol Phosphate Enzyme Based Method with a minimum value of 150 milligram /deciliter and a maximum value of 199 milligram/deciliter is considered normal. Value above 200 milligram/deciliter is considered as increased serum triglycerides
Measured: 12 week
Serum Total Cholesterol
Changes from baseline are measured by Cholesterol Oxidase Enzyme Based Method with a minimum value of 125 and a maximum value of 200 milligram /deciliters considered as normal. Value above 200 milligram/deciliter is considered as hypercholesterolemia.
Measured: 12 weeks
Serum Low Density Lipoproteins (LDL)
Changes from baseline are measured by Friedewald calculation with a minimum value of 100 and a maximum value of 120 milligram /deciliter is considered as normal.
Measured: 12 weeks
Serum High Density Lipoproteins (HDL)
Changes from baseline are measured by Direct Enzymatic Immuno-inhibition with a maximum value of 40milligram/deciliter and higher is considered as normal. Value below 40 milligram/deciliter is considered as abnormal.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start5 Feb 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shazia Ali, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813133
- Sponsor's protocol ID
- IRC/23/233 Tayyaba Anis Ch.
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Domingueti CP, Dusse LM, Carvalho Md, de Sousa LP, Gomes KB, Fernandes AP. Diabetes mellitus: The linkage between oxidative stress, inflammation, hypercoagulability and vascular complications. J Diabetes Complications. 2016 May-Jun;30(4):738-45. doi: 10.1016/j.jdiacomp.2015.12.018. Epub 2015 Dec 18.
PubMed 26781070Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, Sheikh A, Raza A, Fazid S, Jadoon Z, Ishtiaq O, Safdar N, Afridi H, Heald AH. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019 Feb 21;9(2):e025300. doi: 10.1136/bmjopen-2018-025300.
PubMed 30796126Diabetes DOF. DEFINITION AND DESCRIPTION OF DIABETES OTHER CATEGORIES OF GLUCOSE. 2010;33.
Lilly E, Homburg B. P R O G R E S S I O N , Initiating Insulin Therapy in Type 2. 2009;32:0-5.
Majeedkutty NA, Jabbar MA. Physical Therapy for Diabetic Peripheral Neuropathy : A Narrative Review. 30(1):112-25.
Alam U, Riley DR, Jugdey RS, Azmi S, Rajbhandari S, D'Aout K, Malik RA. Diabetic Neuropathy and Gait: A Review. Diabetes Ther. 2017 Dec;8(6):1253-1264. doi: 10.1007/s13300-017-0295-y. Epub 2017 Sep 1.
PubMed 28864841Papanas N, Ziegler D. Risk Factors and Comorbidities in Diabetic Neuropathy: An Update 2015. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):48-62. doi: 10.1900/RDS.2015.12.48. Epub 2015 Aug 10.
PubMed 26676661Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.
PubMed 27445060Education DS. 4 . Lifestyle Management. 2017;40(January):33-43.
Nadi M, Marandi SM, Esfarjani F, Saleki M, Mohammadi M. The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women. Adv Biomed Res. 2017 May 2;6:55. doi: 10.4103/2277-9175.205528. eCollection 2017.
PubMed 28553628Handsaker JC, Brown SJ, Bowling FL, Maganaris CN, Boulton AJ, Reeves ND. Resistance exercise training increases lower limb speed of strength generation during stair ascent and descent in people with diabetic peripheral neuropathy. Diabet Med. 2016 Jan;33(1):97-104. doi: 10.1111/dme.12841. Epub 2015 Jul 17.
PubMed 26108438Andayani TM, Izham M, Ibrahim M, Asdie AH. Comparison of the glycemic control of insulin and triple oral therapy in type 2 diabetes mellitus. 2010;1(April):13-8.
Rahimi N, Samavati Sharif MA, Goharian AR, Pour AH. The Effects of Aerobic Exercises and 25(OH) D Supplementation on GLP1 and DPP4 Level in Type II Diabetic Patients. Int J Prev Med. 2017 Aug 8;8:56. doi: 10.4103/ijpvm.IJPVM_161_17. eCollection 2017.
PubMed 28900535DE BODO RC, ALTSZULER N, DUNN A, STEELE R, ARMSTRONG DT, BISHOP JS. Effects of exogenous and endogenous insulin on glucose utilization and production. Ann N Y Acad Sci. 1959 Sep 25;82:431-51. doi: 10.1111/j.1749-6632.1959.tb44924.x. No abstract available.
PubMed 13814676Donnor T, Sarkar S. Insulin- Pharmacology, Therapeutic Regimens and Principles of Intensive Insulin Therapy. 2023 Feb 15. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK278938/
PubMed 25905175
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Synchronized Lifestyle Modification Program in Peripheral Neuropathy in Insulin Dependent Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT04813133
- Acronym / sponsor ID
- IRC/23/233 Tayyaba Anis Ch.
- Conditions
- Diabetic Neuropathies
- Keywords
- Synchronized Lifestyle Modification Program, Diabetic Neuropathy, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Synchronized Lifestyle Modification Program | Experimental | Other: Synchronized Lifestyle Modification ProgramSynchronized Lifestyle Modification Program |
| Synchronized Lifestyle Modification Program and Physiotherapy | Experimental | Other: Synchronized Lifestyle Modification Program and PhysiotherapySynchronized Lifestyle Modification Program and Physiotherapy |
| Physiotherapy | Experimental | Other: PhysiotherapyPhysiotherapy included Aerobics, Resistance exercise, Flexibility exercise, and Balance exercise. |
| Control Group | No intervention | –No intervention will be given to this Group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both males and females
- Five years duration of clinically diagnosed type 2 Diabetes were included in the study
- On insulin therapy
- Diagnosed to have peripheral neuropathy according to Michigan Neuropathy Screening Instrument with a physical examination score > 2.5
Key exclusion criteria (7 listed)
- Type 1 Diabetics
- Type 2 Diabetics
- 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)
- Patients with foot ulcers and orthopedic or surgical problems of lower limb
- Patients with peripheral vascular diseases, inability to walk independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronized Lifestyle Modification ProgramSynchronization of dietary intake with circadian rhythm of the body. | Other | Synchronized Lifestyle Modification Program |
| Synchronized Lifestyle Modification Program and PhysiotherapySynchronization of dietary intake with circadian rhythm of the body along with Physiotherapy ( Aerobics, flexibility, resistance and balance exercises.) | Other | Synchronized Lifestyle Modification Program and Physiotherapy |
| PhysiotherapyOnly Physiotherapy training which includes ( Aerobics, flexibility, resistance and balance exercises.) | Other | Physiotherapy |
Primary outcome
Lifestyle pattern assessment
Time frame: 12 weeks
Changes from baseline assessed through a self structured questionnaire consisted 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.
Calculation of Body Mass Index
Time frame: 12 weeks
Changes from baseline calculated by measuring height through metal measuring tape in meters and weight in kilograms through potable manual weighing scale. BMI with minimum value of 18.5 and maximum value of 24.5 Kilogram/ square meter. Below 18.5 is considered as underweight and above 24.9 is considered as obese
Measurement of Systolic Blood Pressure
Time frame: 12 weeks
Changes from baseline are assessed by using Mercury Sphygmomanometer with minimum value of 110 millimeter of Mercury and maximum value of 130 millimeter of Mercury. Below 110 millimeter of Mercury is considered as low systolic pressure and above 130 millimeter of Mercury is considered as high systolic pressure
Measurement of Diastolic Blood Pressure
Time frame: 12 weeks
Changes from baseline are assessed by using Mercury Sphygmomanometer with minimum value of 60 millimeter of Mercury and maximum value of 90 millimeter of Mercury. Below 60 millimeter of Mercury is considered as low diastolic pressure and above 90 millimeter of Mercury is considered as high diastolic pressure
Assessment of Presence and Severity of Neuropathy by Michigan Neuropathy Screening Instrument (MNSI)
Time frame: 12 weeks
Changes from baseline are assessed by Michigan Neuropathy Screening Instrument (MNSI) that consists of a history questionnaire comprising of 15 questions related to symptoms of diabetic neuropathy with a score of >7 is considered as abnormal and Physical examination that consists of inspection of foot for deformities, ulcers and callus formation, Ankle reflex and vibration sensation with a score of >2.5 is considered abnormal
Measurement of Peak Latency of Sensory Nerves of lower extremities (Sural and Peroneal)
Time frame: 12 weeks
Changes from baseline are assessed by Nerve Conduction Studies with a maximum value of 4.2 millisecond for sural nerve and 6.1 milliseconds for peroneal nerve are considered normal. Values below 4.2 and 6.1 milliseconds are considered abnormal.
Measurement of Amplitude of Sensory Nerves of lower extremities (Sural and Peroneal)
Time frame: 12 weeks
Changes from baseline are assessed by Nerve Conduction Studies with a value of 2 microvolts for peroneal nerve and 6 microvolts for sural nerve are considered normal. Values below 2 and 6 microvolts were considered abnormal.
Velocity of Sensory Nerves of lower extremities (Sural and Peroneal)
Time frame: 12 weeks
Changes from baseline are assessed by Nerve Conduction Studies with minimum limit of 44 meters /second and maximum limit of 64 meters/second. Value below 44m/sec and above 64m/sec are considered abnormal.
Onset Latency of Motor Nerves (Peroneal and Tibial)
Time frame: 12 weeks
Changes from baseline are assessed by Nerve Conduction Studies with a value of 6.1 milliseconds for both nerves is considered normal. Value below 6.1 milliseconds is considered abnormal.
Amplitude of Motor Nerves (Peroneal and Tibial)
Time frame: 12 weeks
Changes from baseline are assessed by Nerve Conduction Studies with a value of 2 millivolts for peroneal nerve and 3 millivolts for tibial nerve is considered normal. Value below 2 and 3 microvolts is considered abnormal.
Velocity of Motor Nerves (Peroneal and Tibial)
Time frame: 12 weeks
Changes from baseline are assessed by Nerve Conduction Studies with a value of 41 m/sec is considered normal. Value below 41 m/sec is considered abnormal
Assessment of Balance by Berg Balance Scale (BBS)
Time frame: 12 weeks
Changes from baseline are assessed by Berg Balance Scale (BBS) with Low Fall Risk score of 41-56, Medium Fall Risk 21-40, High Fall Risk 0-20
Fasting Blood Glucose
Time frame: 12 weeks
Changes from baseline are measured by glucose oxidase strip method in milligram/deciliter using glucometer with a minimum value of 72 mg/dL and a maximum value of 99mg/dL is considered normal. Value below 72mg/dL is considered as hypoglycemia and value above 99 mg/dL is considered hyperglycemia.
Serum HbA1c concentration
Time frame: 12 weeks
Changes from baseline are measured by Ion Exchange Chromatography with a minimum value of 4% and maximum value of 5.9% is considered normal.
Serum Triglycerides
Time frame: 12 week
Changes from baseline are measured by Glycerol Phosphate Enzyme Based Method with a minimum value of 150 milligram /deciliter and a maximum value of 199 milligram/deciliter is considered normal. Value above 200 milligram/deciliter is considered as increased serum triglycerides
Serum Total Cholesterol
Time frame: 12 weeks
Changes from baseline are measured by Cholesterol Oxidase Enzyme Based Method with a minimum value of 125 and a maximum value of 200 milligram /deciliters considered as normal. Value above 200 milligram/deciliter is considered as hypercholesterolemia.
Serum Low Density Lipoproteins (LDL)
Time frame: 12 weeks
Changes from baseline are measured by Friedewald calculation with a minimum value of 100 and a maximum value of 120 milligram /deciliter is considered as normal.
Serum High Density Lipoproteins (HDL)
Time frame: 2 weeks
Changes from baseline are measured by Direct Enzymatic Immuno-inhibition with a maximum value of 40milligram/deciliter and higher is considered as normal. Value below 40 milligram/deciliter is considered as abnormal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 26781070Domingueti CP, Dusse LM, Carvalho Md, de Sousa LP, Gomes KB, Fernandes AP. Diabetes mellitus: The linkage between oxidative stress, inflammation, hypercoagulability and vascular complications. J Diabetes Complications. 2016 May-Jun;30(4):738-45. doi: 10.1016/j.jdiacomp.2015.12.018. Epub 2015 Dec 18.
- Background: PubMed 30796126Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, Sheikh A, Raza A, Fazid S, Jadoon Z, Ishtiaq O, Safdar N, Afridi H, Heald AH. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019 Feb 21;9(2):e025300. doi: 10.1136/bmjopen-2018-025300.
- BackgroundDiabetes DOF. DEFINITION AND DESCRIPTION OF DIABETES OTHER CATEGORIES OF GLUCOSE. 2010;33.
- BackgroundLilly E, Homburg B. P R O G R E S S I O N , Initiating Insulin Therapy in Type 2. 2009;32:0-5.
- BackgroundMajeedkutty NA, Jabbar MA. Physical Therapy for Diabetic Peripheral Neuropathy : A Narrative Review. 30(1):112-25.
- Background: PubMed 28864841Alam U, Riley DR, Jugdey RS, Azmi S, Rajbhandari S, D'Aout K, Malik RA. Diabetic Neuropathy and Gait: A Review. Diabetes Ther. 2017 Dec;8(6):1253-1264. doi: 10.1007/s13300-017-0295-y. Epub 2017 Sep 1.
- Background: PubMed 26676661Papanas N, Ziegler D. Risk Factors and Comorbidities in Diabetic Neuropathy: An Update 2015. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):48-62. doi: 10.1900/RDS.2015.12.48. Epub 2015 Aug 10.
- Background: PubMed 27445060Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.
- BackgroundEducation DS. 4 . Lifestyle Management. 2017;40(January):33-43.
- Background: PubMed 28553628Nadi M, Marandi SM, Esfarjani F, Saleki M, Mohammadi M. The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women. Adv Biomed Res. 2017 May 2;6:55. doi: 10.4103/2277-9175.205528. eCollection 2017.
- Background: PubMed 26108438Handsaker JC, Brown SJ, Bowling FL, Maganaris CN, Boulton AJ, Reeves ND. Resistance exercise training increases lower limb speed of strength generation during stair ascent and descent in people with diabetic peripheral neuropathy. Diabet Med. 2016 Jan;33(1):97-104. doi: 10.1111/dme.12841. Epub 2015 Jul 17.
- BackgroundAndayani TM, Izham M, Ibrahim M, Asdie AH. Comparison of the glycemic control of insulin and triple oral therapy in type 2 diabetes mellitus. 2010;1(April):13-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shazia Ali, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronized Lifestyle Modification Program, Synchronized Lifestyle Modification Program and Physiotherapy and Physiotherapy in people with Diabetic Neuropathies, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle pattern assessment (time frame: 12 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813133, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.