Diagnostic Models Of Diabetes Mellitus In Idiopathic Recurrent Chronic Pancreatitis Or Early Chronic Pancreatitis To Be Distinguished From Type 2 Diabetes Mellitus- Long Term Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To elucidate the distinct clinical characteristics and management challenges of DM3c in CP, differentiating it from DM2
研究概览
简要总结
This observational cohort study (prospective and retrospective) aims to analyze the phenotype and prevalence of diabetes mellitus in patients with idiopathic recurrent chronic pancreatitis (IRCP) or early chronic pancreatitis (ECP). It will assess the severity of diabetes in relation to pancreatitis, evaluate pancreatic dysfunction, and compare diagnostic models for differentiating Type 3c Diabetes Mellitus (T3cDM) from Type 2 Diabetes Mellitus (T2DM). The study will enroll 70 patients, including a 10% dropout rate, meeting inclusion criteria. The study involves detailed clinical evaluation, structured interviews, physical examinations, Imaging techniques and Functional pancreatic assessments. Patients will undergo standardized glucose tolerance assessments, antibody evaluation and insulin response to differentiate phenotype of diabetes mellitus.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years and above diagnosed with IRCP or ECP, confirmed by clinical, biochemical, and imaging findings.
- •Patients who demonstrate evidence of pancreatic dysfunction, including exocrine insufficiency (e.g., low fecal elastase) or endocrine dysfunction (e.g., impaired glucose tolerance).
- •Patients capable of adhering to study protocols and attending follow-up assessments.
- •Willingness to provide informed consent for participation and data use.
排除标准
- •Patients with secondary causes of pancreatitis, including alcohol-induced, biliary, or hereditary pancreatitis.
- •Patients with pre-existing diabetes unrelated to pancreatitis (e.g., Type 1 or Type 2 diabetes diagnosed before pancreatitis onset).
- •Those with severe systemic illnesses or comorbidities, such as advanced malignancies or end-stage organ failure, that could interfere with study adherence.
- •Pregnant or breastfeeding women, to avoid confounding physiological changes.
- •Patients on medications known to affect pancreatic function, such as corticosteroids or chronic opioid therapy.
结局指标
主要结局
To elucidate the distinct clinical characteristics and management challenges of DM3c in CP, differentiating it from DM2
时间窗: Outcome will be measured at the baseline (One time point study)
次要结局
- 1.Diagnostic criteria
研究者
Dr Rajiv Mehta
SIDS hospital and research centre