| CTRI Number |
CTRI/2023/03/050967 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
role of glucagon in hypoglycemia |
|
Scientific Title of Study
|
Role of alpha and beta cell secretory function in predicting hypoglycemia in patients with Diabetes Mellitus: A hospital based pilot study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohini Rokkam |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Raipur |
| Address |
AIIMS, Tatibandh, Raipur
Department of General Medicine
Raipur
CHHATTISGARH
492099
India |
| Phone |
08374063614 |
| Fax |
|
| Email |
rohinirokkam@aiimsraipur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohini Rokkam |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Raipur |
| Address |
AIIMS, Tatibandh, Raipur
Department of General Medicine
CHHATTISGARH
492099
India |
| Phone |
08374063614 |
| Fax |
|
| Email |
rohinirokkam@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rohini Rokkam |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Raipur |
| Address |
AIIMS, Tatibandh, Raipur
Department of General Medicine
CHHATTISGARH
492099
India |
| Phone |
08374063614 |
| Fax |
|
| Email |
rohinirokkam@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , Raipur |
|
|
Primary Sponsor
|
| Name |
AIIMS, Raipur |
| Address |
All India Institute of Medical Sciences, Tatibandh, Raipur, Chhattisgarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rohini Rokkam |
AIIMS, Raipur |
department of general medicine, AIIMS, Tatibandh
Raipur
CHHATTISGARH |
08374063614
rohinirokkam@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. A confirmed diagnosis of Diabetes on treatment with insulin with or without oral hypoglycemic agents (OHAs) other than insulin secretagogues
2. Informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Chronic kidney disease more than KDIGO stage 3
3. Sepsis
4. Acute coronary syndrome
5. Insulin secretagogue therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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)
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypoglycemia is a major
limiting factor in Insulin initiation in patients with Diabetes Mellitus.
Regulation of blood glucose depends on a fine balance between serum insulin and
serum glucagon. With this study we intend to see if baseline serum C-peptide
(for endogenous beta cell function) and serum glucagon (for alpha cell
function) 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 and
serum glucagon on the first contact with the subject. On the same day, a
continuous 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 the
device and recording the data of the device. The frequency of hypoglycemia
episodes will be correlated with their basal C-peptide and glucagon levels. |