Effect of Gen-Premium as a meal replacement on glycemic control in Type 2 diabetes patients: A randomized controlled trial

Phase 4

Completed

• Conditions: type 2 diabetes patients; type 2 diabetes patients, nutrition

• Registration Number: TCTR20131206002
• Lead Sponsor: Thai Otsuka Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-06
• Study Completion: 2015-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Diagnosed with type 2 DM at least 6 months
2.Age of 18 years and older
3.Subjects with HbA1C 7-9%
4.Subjects with weight changed less than 5% at least 3 months before enrollment
5.Subjects with dyslipidemia, continue stable dose of lipid lowering agent at least 3 months before enrollment
6.Subjects with diet control, insulin, hypoglycaemic agent at least 6 months with unchanged dose at least 3 months before enrollment
7.Willing to participate in the study and sign the inform consent form

Exclusion Criteria

1.Subject with history of severe hypoglycemia with neuroglycopenia
2.Subject with severe complication; amputation, diabetic coma
3.Subject with history of GI dysfunction such as short bowel syndrome, colectomy
4.Subject with cardiovascular diseases; ischemic heart disease, stroke or history of heart failure within 6 weeks before enrollment
5.Subject with significant abnormal laboratory value such as hemoglobin < 10 g/dL, WBC < 3000 x 103/L, platelet < 100,000 x 103/L, AST or ALT > 3 times upper limit of normal, total bilirubin > 2 times upper limit of normal
6.Subject with GFR < 60 mL/min/1.73m2
7.Subject with psychiatric disorder, alcoholism, drug addiction
8.Subject with active thyroid dysfunction
9.Subject with malignancy within 5 years before enrollment
10.Pregnancy or lactation or refuse effective birth control method
11.Subject with herbal, supplements or steroids (except topical steroid) at least 7 days consecutively; or on other investigational drugs within 4 weeks before enrolment
12.Subject who is allergic to whey protein isolate (WPI), soy protein isolate, fish oil (except diarrhea from lactose intolerance)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Statistical different of HbA1C level at baseline and day91. Baseline & day 91 significant level of 0.05

Secondary Outcome Measures

Name	Time	Method
Statistical different of 2-hour postprandial plasma glucose of reference food and Gen-Premium, and p Baseline & day 91 significant level of 0.05