| CTRI Number |
CTRI/2025/11/098096 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
what would be effect of carbohydrate containing drink given to diabetic patients before surgery on blood sugar levels and hospital stay. |
|
Scientific Title of Study
|
To assess the effect of preoperative oral carbohydrate electrolyte drink on postoperative insulin resistance in diabetic patients undergoing gastro-intestinal surgery : a randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Singh |
| Designation |
Associate professor |
| Affiliation |
Indira gandhi institute of medical sciences, patna |
| Address |
Department of Anaesthesiology,
Indira gandhi institute of medical sciences, patna
Patna
BIHAR
800014
India |
| Phone |
9878309230 |
| Fax |
|
| Email |
drswatisingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Singh |
| Designation |
Associate professor |
| Affiliation |
Indira gandhi institute of medical sciences, patna |
| Address |
Department of Anaesthesiology,
Indira gandhi institute of medical sciences, patna
Patna
BIHAR
800014
India |
| Phone |
9878309230 |
| Fax |
|
| Email |
drswatisingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Singh |
| Designation |
Associate professor |
| Affiliation |
Indira gandhi institute of medical sciences, patna |
| Address |
Department of Anaesthesiology,
Indira gandhi institute of medical sciences, patna
Patna
BIHAR
800014
India |
| Phone |
9878309230 |
| Fax |
|
| Email |
drswatisingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira gandhi institute of medical sciences, bailey road, Patna, Bihar, india, pin-800014 |
|
|
Primary Sponsor
|
| Name |
Dr. swati singh |
| Address |
Anaesthesia department, Indira gandhi institute of medical sciences, patna, Bihar 800014 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Swati singh |
Indira gandhi institute of medical sciences |
Anaesthesia department, Indira gandhi institute of medical sciences, bailey road
Patna
BIHAR |
9878309230
drswatisingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Malotodextrin |
Group ME- patient will receive 400 ml, 12 hours before surgery and 200 ml of Malotodextrin, 3 hours before surgery.
|
| Comparator Agent |
maltodextrin |
Group E- patient will receive 400 ml of maltodextrin on the evening before surgery
|
| Comparator Agent |
Normal saline |
Group C - Patient will receive 400 ml of NS 12 hours and 3 hours before surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Diabetes Mellitus Type 2 undergoing elective gastric surgery,
colorectal surgery (CRS) with FBS less than 200 mg/dl and HbA1c less than 7 will be included.
2. Expected postoperative hospital stay of more than 72 h. |
|
| ExclusionCriteria |
| Details |
1. patients undergoing emergency surgery or secondary surgery
2. patients with inability to receive enteral nutrition
3. patients with comorbidities to ensure the safety of the trial and minimize
the occurrence of adverse events
4. patients with mental disorders, alcohol addiction, or drug abuse history
5. lactating and pregnant women
6. patients with allergy to maltodextrin and various drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is insulin resistance assessed
by HOMA-IR on postoperative day 1. |
24 hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes will be
Perioperative glycemia, length of stay, fasting blood glucose, fasting insulin,
insulin secretion index, insulin sensitivity index, intraoperative and post
operative blood glucose upto 24 h post-surgery. |
upto 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
01/01/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of this study is to investigate whether shortening the preoperative fast using a solution containing carbohydrates can alter the acute-phase response and clinical outcomes of elective major operations of the digestive tract by assessing insulin resistance by HOMA-IR on postoperative day 1 and also assessing Perioperative glycemia, length of stay, fasting blood glucose, fasting insulin, insulin secretion index, insulin sensitivity index, intraoperative and post operative blood glucose upto 24 h post-surgery. |