跳至主要内容
临床试验/CTRI/2023/03/050967
CTRI/2023/03/050967尚未招募不适用

Role of alpha and beta cell secretory function in predicting hypoglycemia in patients with Diabetes Mellitus: A hospital based pilot study

AIIMS, Raipur1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年10月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
the correlation between basal serum glucagon level and incident hypoglycemia in DM patients on insulin based therapy during a follow up period of 2 weeks.

研究概览

简要总结

Hypoglycemia is a majorlimiting factor in Insulin initiation in patients with Diabetes Mellitus.Regulation of blood glucose depends on a fine balance between serum insulin andserum glucagon. With this study we intend to see if baseline serum C-peptide(for endogenous beta cell function) and serum glucagon (for alpha cellfunction) can predict the risk of hypoglycemia in insulin treated DM patients.After enrolment in the study and due consent, we will be drawing samples at 0,1h and 3h after a standard meal to assess blood glucose, serum C-peptide andserum glucagon on the first contact with the subject. On the same day, acontinuous glucose monitoring device will be applied on the arm of the subject.The patient will be called for follow up after 14 days for removal of thedevice and recording the data of the device. The frequency of hypoglycemiaepisodes will be correlated with their basal C-peptide and glucagon levels.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.A confirmed diagnosis of Diabetes on treatment with insulin with or without oral hypoglycemic agents (OHAs) other than insulin secretagogues 2.Informed consent.

排除标准

  • 1.Pregnancy 2.Chronic kidney disease more than KDIGO stage 3 3.Sepsis 4.Acute coronary syndrome 5.Insulin secretagogue therapy.

结局指标

主要结局

the correlation between basal serum glucagon level and incident hypoglycemia in DM patients on insulin based therapy during a follow up period of 2 weeks.

时间窗: 14 days

次要结局

  • 1.The correlation between basal serum glucagon level and time in target range in insulin treated DM patients by using CGMS.(2.The correlation between basal serum C-peptide with time in target range (TIR))

研究者

发起方
AIIMS, Raipur
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验