Clinical Research Directory

Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients

Diabetes Mellitus is considered as one of the most prevalent issues among global population and 50% of all the diabetic patients particularly diabetes type II develop peripheral neuropathy. Diabetic Peripheral Neuropathy (DPN) affects feet and legs first, followed by the hands and arms. This study will involve two groups, one performing the Otago Exercise Program, and the other performing a combined PNF and Otago exercise protocol. This study aims to assess the additional effects of Proprioceptive Neuromuscular Facilitation with Otago Exercise Program on Risk of fall which will be assessed by assessing balance, Fear of Fall and Sensory Function. Key outcome measures, including the Berg Balance Scale, Fall Efficacy Scale, Functional Reach test and Semmes Weinstein Monofilament Test will be used in evaluating the effectiveness of the exercise interventions. The participants would be screened through Michigan Neuropathy Screening Instrument and Berg Balance scale for inclusion criteria, and outcome measures will be assessed by using Berg Balance Scale, Fall efficacy scale, Functional Reach Test and Semmes Weinstein Monofilament testing method on the day of starting the intervention and on the last day of intervention. Intervention will be given for a total of 40-50 minutes per session, 3 sessions/week for consecutive 6 weeks And than the data will be recorded at the end of 6 weeks again.

Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.

The goal of this clinical trial is to test in patients with diabetic neuropathy, * Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up. * Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg/day)+EPALRESTAT (150 mg/day) conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up * All potential participants will undergo screening- about 10 ml of blood will be drawn to perform the following assesments at screening- HbA1c, FBS,Vit B12, TSH, fT4. * Baseline assessments conducting a nerve conduction study, quality of life assesment using Eq-5D-5L and NRS pain score. * 20% of patients (24 patients) will undergo Sudoscan, Corneal confocal microscopy and a skin biopsy for assessing IENFD (Intra Epidermal Nerve Fibre Density). * 15th day, 1 month and 3rd month followup for evaluating patients status and medication adherance. * 6th month followup for evaluating patients status and medication adherance. Researchers will compare Nebivolol against combination of Epalrestat+Alpha Lipoic Acid against standard pain modulating treatment to evaluate their diseaes modifying effect as reflected by nerve conduction study parameters.

Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy

Objectives: The goal of this cross sectional clinical trial is to examine the phenotype of bone disease in type 2 diabetes.The main aims are to: 1. Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures. 2. Examine how autonomic and peripheral neuropathy affects bone microarchitecture, bone material strength and bone turnover markers as well as postural control in T2D. Methods: The trial is of cross-sectional design and consists of examinations including * Blood samples to analyze bone markers, glycemic state i.e. * Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure. * Microindentation to evaluate bone material strength * Skin autofluorescence to measure levels of advanced glycation endproducts (AGEs) in the skin * Assesment of nerve function (peripheral and autonomic) * Assesment of postural control, muscle strength and gait Participants: A total of 300 type 2 diabetes patients divided to three groups: * 160 with no history of fractures or diabetic neuropathy * 100 with a history of fracture(s) * 40 with autonomic neuropathy or severe peripheral neuropathy

Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients

Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy. The data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.