Comparative Clinical Study on Collagen Peptide and resistant dextrin (nutritional supplements) in patients with type 2 diabetes mellitus.

Not Applicable

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2017/05/008464
• Lead Sponsor: itta Gelatin India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-23
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Male and female adults between the ages of 21 and 50 years (both ages inclusive).

2.Subjects with known history/diagnosis of diabetes mellitus (type II).

3.Subjects who are on standard therapy of Sitagliptin for management of diabetes mellitus (type II).

4.Subjects who have no known history or diagnosis of complications association with diabetes mellitus (type II).

5.Subjects who are non-alcoholic and non-smokers/non-users of tobacco.

6.Subjects with Body Mass Index between 18 to 32 kg/m2, both values inclusive.

7.Subjects with normal presentations during physical examination and laboratory investigations â?? complete blood count and serum biochemistry

Exclusion Criteria

1.Subjects who are vegetarians or vegans who object to consumption of animal origin products.

2.Subjects on herbal, ayurvedic, homeopathic medications for the control of diabetes mellitus.

3.Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.

4.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.

5.Subjects who are on steroids, hormone therapy, anti-depressants, anti-psychotics.

6.Subjects who have no modified their dosage of standard therapy within one month of randomisation.

7.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.

8.Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method.

9.Subjects who in the opinion of the investigator are deemed unfit to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Fasting Blood Glucose: Prediabetic or normal levels of blood glucose levels <br/ ><br>2.HbA1C: Prediabetic or normal levels of glycated haemoglobin levels <br/ ><br>3.Insulin Resistance: Remarkable reduction of HOMA IR <br/ ><br>4.Fasting Lipid Profile: Remarkable reduction in cholesterol and triglyceride values <br/ ><br>5.Quality of Life Questionnaire: Remarkable improvement in the quality of life of the subjectTimepoint: 1.Fasting Blood Glucose: Prediabetic or normal levels of blood glucose levels <br/ ><br>2.HbA1C: Prediabetic or normal levels of glycated haemoglobin levels <br/ ><br>3.Insulin Resistance: Remarkable reduction of HOMA IR <br/ ><br>4.Fasting Lipid Profile: Remarkable reduction in cholesterol and triglyceride values <br/ ><br>5.Quality of Life Questionnaire: Remarkable improvement in the quality of life of the subject

Secondary Outcome Measures

Name	Time	Method
1.Fasting Blood Glucose Levels: Moderate reduction in blood glucose levels <br/ ><br>2.HbA1C: Moderate reduction in glycated haemoglobin levels <br/ ><br>3.Insulin Resistance: Moderate reduction in baseline <br/ ><br>4.Fasting Lipid Profile: Moderate reduction in cholesterol and triglyceride values <br/ ><br>5.Quality of Life Questionnaire: Moderate improvement in the quality of life of the subject. <br/ ><br>Timepoint: 1.Fasting Blood Glucose Levels: At Visit 0, Visit 2 (3rd week), visit 3(6th week), visit 4(9th week) and visit 5 (12th week). <br/ ><br>2.HbA1C: At Visit 0, Visit 3(6th week), Visit 5(12th week). <br/ ><br>3.Insulin Resistance: At Visit 0, Visit 5(12th week). <br/ ><br>4.Fasting Lipid Profile: At Visit 0, Visit 5(12th week). <br/ ><br>5.Quality of Life Questionnaire: At Visit 1, Visit 2(3rd week), Visit 3(6th week), Visit 4(9th week), Visit 5(12th week). <br/ ><br>