| CTRI Number |
CTRI/2011/10/002089 [Registered on: 24/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
10/09/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food product] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An open-label, randomized, crossover, pilot study to assess the efficacy of Nutren diabetes, in maintenance of blood glucose level in patients with type 2 diabetes (T2DM) |
|
Scientific Title of Study
|
An open-label, randomized, crossover, pilot study to assess the efficacy of Nutren diabetes, in maintenance of blood glucose level in patients with type 2 diabetes (T2DM) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 10.01.IN.CLI. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Partha Chatterjee |
| Designation |
Associate Director, Project Management |
| Affiliation |
|
| Address |
SIRO Clinpharm Pvt. Ltd
DIL Premises, 2nd Floor,
Off Ghodbunder Road,
Opp Tatwagyan Vidyapeeth,
Thane West
Thane
MAHARASHTRA
400610
India |
| Phone |
02225848066 |
| Fax |
|
| Email |
partha.chatterjee@siroclinpharm.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Partha Chatterjee |
| Designation |
Associate Director, Project Management |
| Affiliation |
|
| Address |
SIRO Clinpharm Pvt. Ltd
DIL Premises, 2nd Floor,
Off Ghodbunder Road,
Opp Tatwagyan Vidyapeeth,
Thane West
Thane
MAHARASHTRA
400610
India |
| Phone |
02225848066 |
| Fax |
|
| Email |
partha.chatterjee@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Partha Chatterjee |
| Designation |
Associate Director, Project Management |
| Affiliation |
|
| Address |
SIRO Clinpharm Pvt. Ltd
DIL Premises, 2nd Floor,
Off Ghodbunder Road,
Opp Tatwagyan Vidyapeeth,
Thane West
Thane
MAHARASHTRA
400610
India |
| Phone |
02225848066 |
| Fax |
|
| Email |
partha.chatterjee@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nestle |
| Address |
Nestle India Limited
Nestle House
Jacaranda Marg, M Block,
DLF City, Phase II,
Gurgaon - 122002 (Harayana) |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Anoop Misra |
Fortis Flt. Lt. Rajan Dhall Hospital |
Centre of Excellence in Diabetes, Obesity, Metabolic Diseases and Endocrinology
Fortis Flt. Lt. Rajan Dhall Hospital
Sector B, Pocket 1 Aruna Asaf Ali Marg
Vasant Kunj
New Delhi - 110 070
India
South
DELHI |
011-41759672
anoopmisra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutren Diabetes |
Nutren diabetes; 55 gm in 210 ml of water as a single dose on one occasion via oral administration. |
| Comparator Agent |
The reference product: Cornflakes and Milk |
250 ml of double toned milk with 42 gm of Kelloggs cornflakes. The reference product will deliver 261 kcal of energy. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient has a known history of diabetes (T2DM) and is currently on antihyperglycemic drugs.
2. The patient has good diabetes control defined as baseline HbA1c levels of 7.0-9.0%
3. The patient is male or female, and is ≥35 and ≤60 years of age
4. The patient is capable of understanding and complying with the protocol requirements
5. The patient signs a written, informed consent form prior to the initiation of any study procedures
6. The patient has a fasting blood glucose less than 180 mg
7. The patient has a stable weight; no loss/gain of a maximum of 10% of their body weight within the past 6 months |
|
| ExclusionCriteria |
| Details |
1. The patient has symptoms of very poor diabetes control defined as HbA1c > 9%.
2. The patient is on insulin therapy for management of diabetes.
3. The patient has serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse.
4. The patient has participated in any other investigational study within 30 days prior to initiation of the study.
5. The patient is currently using other diabetic nutritional supplements sharing the same mechanism of action as Nutren Diabetes.
6. The patient is a study site employee, or is an immediate family member (ie, parent, child, and sibling) of a study site employee, involved in conduct of this study.
7. The patient has history of hypersensitivity to any of the ingredients of Nutren.
8. The patient has history of hypersensitivity to any of the ingredients of test meal.
9. If the patient is female, the patient is pregnant or lactating.
10. The patient has any condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for the study.
11. The patient is unable to understand to comply with the instructions.
12. The patient is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy outcome for this study is reduction in postprandial blood glucose level over stipulated time points (30, 60, 90, 120, and 180 minutes) form baseline (0 min). This parameter is considered one of the standards for the determination of blood glucose control. |
0, 30, 60, 90, 120, and 180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary efficacy outcome for this study is change in insulin level over stipulated time points (30, 60, 90, 120, and 180 minutes) from baseline (0 min) and triglycerides level at 120 min from fasting state as the intake of any food product is directly related the lipid content. Also subjective sensations of hunger, satiety, and other appetite sensations will be assessed for the patients using a VAS questionnaire. |
0, 30, 60, 120 and 180 minutes. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be an open-label, randomized, single-center, 2-period, cross over, pilot study in patients with T2DM to determine the efficacy of Nutren diabetes, a nutritional supplement, in maintenance of blood glucose level in patients with T2DM. The study will consist of a Pre-Treatment Phase and a Treatment Phase. The Pre-Treatment Phase will consist of Screening Period followed by a Run-in Period. During the Screening Period (Day -14 to Day -8) the patients will be evaluated to determine if they meet the Inclusion/Exclusion criteria. During the Run-in period (Day -7 to Day -1) the patients will be advised on the diet and exercise to be followed. The Run-in Period is included in this study to ensure that all patients receive the same nutrition counseling and advise in order to bring homogeneity in the study. At the end of Run-in Period the patients will be randomized to one of the study groups. The Treatment Phase will consist of 2 periods of 1 day each, separated by a washout period of 1 week and a follow up period of 2 days. During each period, the patients will be confined to the clinic and will be administered either the test product or isocaloric diet as per the randomization schedule. The test product will be given as a meal replacement in the morning after overnight fast; only water will be allowed. Blood samples will be collected for estimation of blood glucose level and triglyceride levels at stipulated time points. The subjects will also be asked to fill a questionnaire on Day 1 and Day 8 for assessing the patient’s sensations of hunger, satiety, and other appetite sensations as per schedule of assessments. Subjects will be released from the clinic on same day after completion of all study related procedures. The patients will be followed up through telephone for safety assessments at the end of Period 2 for 2 days. |