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临床试验/CTRI/2026/01/100237
CTRI/2026/01/100237尚未招募不适用

Prevalence of Unhealthy Dietary Patterns Among Prediabetic and Diabetic Individuals: A Cross-Sectional Study

All India Institute of ayurveda1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
1.Primary Outcome Measure

研究概览

简要总结

Title Prevalence of Unhealthy Dietary Patterns Among Prediabetic and Diabetic Individuals A Cross Sectional Study

Introduction

The study focuses on diabetes and prediabetes which are metabolic disorders caused by defects in insulin action or secretion. Prediabetes is an early stage of diabetes where blood sugar levels are above normal but not yet diabetic. Dietary patterns play an important role in determining the risk of diabetes. Ayurveda describes Prameha as a disorder caused by improper food and lifestyle leading to obstruction in body channels called srotas. This study aims to assess the association between dietary patterns and Srotodushti in diabetic and prediabetic individuals to develop preventive dietary strategies integrating Ayurvedic and modern approaches.

Need of the Study

Diabetes and prediabetes are rapidly increasing in both rural and urban areas of India due to lifestyle and diet changes. Research shows that type 2 diabetes can be prevented through proper diet and physical activity. Ayurveda identifies improper food and lifestyle as main causes of Srotodushti leading to Prameha, but few studies have examined this link. Hence, this study is needed to bridge Ayurvedic understanding with modern evidence.

Literature Review

Classical Ayurvedic texts like Charaka Samhita, Susruta Samhita, and Astanga Hridaya describe the causes, pathogenesis, symptoms, and dietary aspects of Prameha and Srotodushti. They explain how imbalance in doshas and medas leads to disease progression. Modern studies show that unhealthy diets rich in refined carbohydrates, fats, and animal protein increase diabetes risk while diets with fruits, vegetables, and fiber are protective. The literature supports the need to analyze overall dietary patterns and their role in metabolic and Ayurvedic parameters.

According to Sushruta Nidana 6 In individuals indulging in improper diet and lifestyle, the immature doshas vata, pitta, and kapha mix with medas or fat tissue. These vitiated doshas travel through the urinary channels called mutravaha srotas and get localized near the bladder region.

According to Charaka Nidana 4

Due to indulgence in etiological factors, especially kapha-dominant ones, the kapha dosha becomes aggravated and spreads throughout the body. Because of the similarity in properties between kapha and medas, the vitiated kapha mixes with medas, leading to the vitiation of fat tissue. The vitiated kapha and medas then combine with mamsa and kleda, causing the formation of carbuncles and other symptoms. This disturbed fat and moisture also affect the urinary channels, leading to blockage and the manifestation of prameha. As the disease involves multiple dhatus and is deeply rooted, it often becomes chronic and difficult to cure.

According to Charaka Sutra 28

Premonitory symptoms of prameha, such as excessive urination and obesity, arise from the vitiation of medas. Individuals with disturbed fat metabolism are more prone to develop diabetes in the future. The main causes of medovaha srotodushti include lack of exercise, sleeping during daytime, excessive intake of fatty, fried, and calorie-rich foods, and overconsumption of alcohol.

According to Charaka Chikitsa

In terms of prognosis, prameha caused by kapha and pitta dosha, when preceded by their early symptoms, is generally incurable. Vata-dominant prameha that occurs in the later stage is also incurable. Pitta-dominant types are manageable but not easily cured. However, when medas is not severely vitiated, the disease can be curable with proper treatment and lifestyle correction.

 Research Question

Is there an association between dietary pattern and Srotodushti manifestation among prediabetic and diabetic individuals

Hypothesis

There is an association between dietary pattern and Srotodushti manifestation in prediabetic and diabetic individuals.

Aim

To evaluate the association between dietary pattern and Srotodushti manifestation in prediabetic and diabetic patients.

Objectives

To assess the prevalence of unhealthy dietary patterns in prediabetic and diabetic individuals. To evaluate the relationship between dietary patterns and Srotodushti symptoms. To study the association of dietary patterns and Medovaha Srotodushti with biological parameters like lipid profile and HbA1c. To assess the relationship between physical activity and Srotodushti.

Materials and Methods

This is a two year observational cross sectional study conducted at the Metabolic and Lifestyle Disorder Outpatient Department of the All India Institute of Ayurveda. Convenience sampling will be used. About 200 participants aged 30 to 60 years diagnosed with prediabetes or diabetes will be included. Data will be collected through validated questionnaires on diet, Srotodushti symptoms, and physical activity along with anthropometric and biochemical measurements.

Questionnaire Development and Validation

The questionnaire will be developed through item generation, response selection, pre testing for face and content validity, and reliability testing using test retest and internal consistency methods.

Construction of Dietary Pattern by Factor Analysis

A North Indian Food Frequency Questionnaire will be used. Similar food items will be grouped, and factor analysis using varimax rotation will identify dietary patterns. Patterns with eigen value greater than one will be retained. Factor scores will indicate adherence to specific patterns.

Data Collection

Information will be collected through dietary assessment, Srotodushti symptom questionnaire, physical activity evaluation, anthropometric measurements, and biochemical tests like HbA1c, fasting and postprandial glucose, and lipid profile. Data will be entered electronically after informed consent.

Sample Size Calculation

Using a 95 percent confidence level and 7 percent precision, the required sample size is 196. Considering 10 percent dropout, the final sample size is fixed at 200 participants.

Statistical Analysis

Descriptive statistics will summarize the data. Normality will be tested using Shapiro Wilk test. Correlation and regression analyses will examine associations between dietary pattern, Srotodushti symptoms, and biochemical parameters. ANOVA or Kruskal Wallis tests will compare groups based on severity of Medovaha Srotodushti.

Inclusion Criteria

Adults aged 30 to 60 years of both genders. Diagnosed with prediabetes or type 2 diabetes based on American Diabetes Association criteria. Participants consuming North Indian food.

Exclusion Criteria

Individuals with type 1 or secondary diabetes, major systemic diseases, long term steroid use, pregnancy, psychiatric illness, special diets, food allergies, or those unwilling to participate will be excluded.

Assessment

Srotodushti assessment will include subjective symptoms, objective clinical findings, and standard diagnostic criteria for prediabetes and diabetes. Biochemical investigations will include HbA1c and lipid profile.

Standard Operating Procedures

Blood samples will be collected by trained personnel under sterile conditions. Samples will be stored and processed as per standard guidelines. Biomedical waste will be disposed of according to institutional policy.

Outcome Measures

Primary outcome is the prevalence of unhealthy dietary patterns in diabetic and prediabetic individuals. Secondary outcomes include association between diet, physical activity, and Srotodushti symptoms along with biochemical indicators.

 Observation and Results Baseline data will include demographic, dietary, physical activity, and biochemical parameters. Scores will be computed for dietary behavior, physical activity, and Srotodushti severity.

Ethical Considerations

Informed consent will be obtained. Participants’ privacy and data confidentiality will be maintained. There are no significant risks except mild discomfort during blood sampling. The study follows ethical guidelines and ensures voluntary participation without financial benefits.

Translational Value

This research connects Ayurvedic understanding of Srotodushti with modern clinical findings like HbA1c. It aims to identify early metabolic disturbances and provide holistic preventive strategies to reduce diabetes risk.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Demographic Characteristics Adults aged 30 to 60 years Both males and females
  • Study Specific Variables Diagnosed with prediabetes and diabetes based on American Diabetes Association Prediabetes Fasting Plasma Glucose 100 to 125 mg per dL Postprandial Plasma 140 to 199 mg per dL HbA1c: 5.7 to 6.4 percent Type 2 Diabetes Mellitus FBS greater than or equal to 126 mg per dL or HbA1c greater or equal to 6.5 percent or PPBS greater than or equal to 200 mg per dL
  • Participants consuming north Indian food.

排除标准

  • Individuals with diagnosed type I diabetes mellitus 2 Patients with secondary diabetes due to endocrine disorder, steroid use or pancreatic disease
  • Have a history of major systemic diseases, for example, renal failure, chronic liver disease, or heart failure.
  • Are taking long-term steroid therapy or other medications known to influence glucose metabolism.
  • 5 are currently pregnant or lactating, as pregnancy affects metabolism and dietary patterns.
  • Have a known psychiatric illness or cognitive impairment that may compromise their ability to provide accurate dietary and symptom-related responses.
  • Have known food allergies or specific dietary restrictions that significantly alter dietary patterns, for example, celiac disease or severe food allergies.
  • Individuals on special or restricted diets, for example, ketogenic or gluten-free, and habits like smoking
  • Decline to provide informed consent.

结局指标

主要结局

1.Primary Outcome Measure

时间窗: at baseline at the time of enrollment

The prevalence of unhealthy dietary pattern in prediabetic and diabetic patients.

时间窗: at baseline at the time of enrollment

次要结局

  • 2.Secondary Outcome Measures(Association between dietary habits and Srotodushti symptoms in prediabetic and diabetic individuals.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kokila K

All India Institute of ayurveda

研究点 (1)

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