| CTRI Number |
CTRI/2015/07/006015 [Registered on: 16/07/2015] Trial Registered Prospectively |
| Last Modified On: |
15/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of dietary fiber to improve blood sugar levels in patients having Type II Diabetes |
|
Scientific Title of Study
|
A clinical study to determine the effect of a dietary fiber on plasma glucose levels in patients with Type II Diabetes Mellitus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| T2DM-DF-2015 version 1.0 dated 20 Feb 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre, Jehangir Hospital premises, 32 Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre, Jehangir Hospital premises, 32 Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre Pvt Ltd |
| Address |
Jehangir Clinical Development Centre, Jehangir Hospital premises, 32 Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mr Ajay Nilawar |
| Address |
5-A, Anupam Society,
S H Paralkar Road,
Shivaji Park, Dadar, West
Mumbai 400028 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Almas Pathan |
Jehangir Clinical Development Centre Pvt Ltd |
JCDC, Clinical Research Dept, Jehangir Hospital Premises, 32 Sassoon Road, Pune-411001
Pune
MAHARASHTRA |
91-9763002830
almas.jikare@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type II Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary Fiber |
It is a sachet of 5gms. It is to be dissolved in a glass of water and to be taken with meals. Dose: 5 grams twice daily for duration of 4 weeks. (Subject will be instructed to take one sachet along with water once with lunch and once with dinner). |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Males and females 18 -65 years of age (both inclusive).
• Diagnosed with type 2 diabetes mellitus
• Fasting sugar greater than equal to 126 mg/dl and/or PP sugar greater than equal to 200 mg/dl
• Stable dose of the anti-diabetic treatment in a period of 30 days prior to screening.
• No plan to change the anti-diabetic treatment during subject’s participation in the study as judged by the Investigator at screening.
• BMI less than or equal to 30 kg/m².
• Must have adequate reports of the fasting and PP sugars of past 1 month from screening.
• Must be willing to or likely to comply with all study requirements.
• Must be able and willing to provide written informed consent.
• Females of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
|
|
| ExclusionCriteria |
| Details |
• Use of insulin.
• Suffering from any chronic diseases or serious complications that may interfere with glucose metabolism which in opinion of the Investigator precludes trial participation.
• Suffering from gastrointestinal diseases which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. subacute obstruction.
• Current use of medication which in opinion of the Investigator may interfere with the digestion and nutrient absorption (for examples steroids, protease inhibitors or antipsychotics medications).
• Current use of medication which in opinion of the Investigator is known to affect glucose tolerance (excluding oral contraceptives) and glucose estimation.
• Known food allergy or intolerance, abuse of drugs or alcohol.
• Known case of sensitivity to Gluten or Coeliac disease.
• Pregnant or lactating females.
• Presence of any clinically significant medical conditions or medications which in the opinion of the investigator would make the subject unsuitable for participation in the study.
• Currently participating or had participated in any other interventional study in last 1 month prior to screening
• Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, inability to attend study visits required by the protocol).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect on the fasting and post prandial (PP) in patients with Type II Diabetes Mellitus. |
Week 2, 3 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/07/2015 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a study in subjects with Type II diabetes mellitus.The main purpose of this study is to determine the effect of a dietary fiber in patients with type II Diabetes mellitus.Subjects who meet the eligibility criteria will be enrolled into the study. At the screening visit, retrospective data of subject’s blood sugars will be collected. In addition, fasting and PP sugars will be assessed at screening, week 2/ day 15, week 3/Day 22 and week 4/Day 29.
|