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临床试验/CTRI/2023/07/055208
CTRI/2023/07/055208尚未招募4 期

Counselling with Lifestyle Modification in Vitamin B12 deficient Diabetic Patients, its Correlation with Peripheral Neuropathy

Jahnvi Sharma1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2023年7月23日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
252
试验地点
1
主要终点
There will be no significant difference in the severity of peripheral neuropathy after the dietary & lifestyle intervention.

研究概览

简要总结

This study is undertaken to assess the nutritional status of diabetic patient and intervention for the vitamin b12 deficient patients through diet and modification of lifestyle. Also see the correlation of vitamin b12 level and the peripheral neuropathy. The research design will be Interventional and correlational . Subject will be the diabetic patient from the age group of 35-75 years.  The sample size will be 256 Diabetic patients from OPD of Sir Sunderlal Hospital, Varanasi. Data collection of demographic profile, socio economic status and medical history of the respondents. After that anthropometric data (height, weight, BMI) and then data collection of diet intake within 24 hours by 24 hours food recall method. (3 consecutive days). Assessment of Biochemical parameters (FBS, PP, HbA1C, Vit B12, homocysteine level, lipid profile, Hb, MCV) which advise by doctor and examined in pathology in the supervision of doctor. With the help  of the screening tool MNSI Questionnaire to evaluation of the severity of peripheral neuropathy of each patient. Analysis of the data before and after 8 weeks follow up.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
35.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient with Type 2 Diabetes Mellitus (Age group: 35-75yrs).
  • 2.Patient have Diabetes >6 months.

排除标准

  • 1.Pregnant, Type1 diabetic patients, Alcoholic.
  • 2.Respondents with lactose intolerance, severe hepatic, renal disorder and other chronic complications.
  • 3.Respondent having any supplement or other experimental medicine.

结局指标

主要结局

There will be no significant difference in the severity of peripheral neuropathy after the dietary & lifestyle intervention.

时间窗: 2 months

There will be no association of dietary & lifestyle intervention & vitamin B12 serum level of the diabetic Patient.

时间窗: 2 months

次要结局

  • There will be no correlation of homocysteine level & Vitamin B12 level in blood of the diabetic patient.(There will be no correlation of vitamin B12 level & severity of peripheral neuropathy.)

研究者

发起方
Jahnvi Sharma
申办方类型
Other [self]

研究点 (1)

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