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)

Not Applicable

Completed

• Conditions: Health Condition 1: null- Type 2 Diabetes

• Registration Number: CTRI/2011/10/002089
• Lead Sponsor: estle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.Timepoint: 0, 30, 60, 90, 120, and 180 minutes

Secondary Outcome Measures

Name	Time	Method
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.Timepoint: 0, 30, 60, 120 and 180 minutes.