A Study to Evaluate the Postprandial Metabolic Response After Use of Glucerna SR in Obese Type 2 Diabetes

Obesity Clinical Trial

Official title:

An Open Label, Randomized, and Parallel Study to Evaluate the Postprandial Metabolic Response After 24-Week Use of Glucerna SR in Obese Asian Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631774
• Other study ID #: GSR Version 2
• Status: Completed
• Phase: N/A
• First received: March 2, 2008
• Last updated: December 5, 2011
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: December 2011
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of each subject's participation will be approximately 28 weeks, including a lead-in period of 2 weeks and a 2-week post-treatment telephone follow-up. A sufficient number of Asian subjects with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. Approximately 60 participants will be randomized to receive either (1) a meal replacement program with Glucerna SR on top of the Exchange-diet plan (EDP) or (2) an caloric-matched EDP only. The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes

Description:

A sufficient number of Asian subjects (expected to be approximately 90) with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. The eligible obese subjects with type 2 diabetes will be entered into a 2-week lead-in period with EDP after individual diet/lifestyle consultation to implement nutrition therapy into their existing diabetes management. The diet recommendations of the EDP at the lead-in period will be based on the nutrition recommendations from the ADA including carbohydrate and monounsaturated fat together provided 60-70 % of energy intake, reduced intakes of saturated fat (< 10 % of total calories) and cholesterol (< 300 mg/day) and protein intake around 15-20 % of total daily energy.

Approximately 60 participants will be randomized at Week 0 (Visit 3) in a 1:1 ratio to receive either (1) a meal replacement program with Glucerna SR on top of the EDP or (2) an caloric-matched EDP only. The participants will receive an educational program of diet, exercise, and behavioral strategies at randomization. Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with EDP only will receive a meal plan like they have in the lead-in period. All study subjects will be placed on a diet plan with 500 ~ 800 kcal/day less than their estimated daily maintenance energy requirement and receive an individualized exercise prescription to facilitate an optimal diabetes management. The participants will visit the clinics at 4-week intervals for 24 weeks after randomization to evaluate the efficacy and the safety parameters. The participants will receive two different meal tests at both the baseline and the end of the study. The macronutrient composition in the meal test protocol 1 is a 480 Kcal Glucerna SR breakfast with 50 % CHO, 20 % protein, and 30 % fat. The test meal protocol 2 is a 480 Kcal sandwich breakfast with 63 % CHO, 20 % protein, and 17 % fat. The primary efficacy variable will be the change from baseline in incremental area under curve (∆AUC) of glucose response after a Glucerna-SR test meal between the two groups.

A telephone follow-up will be performed 2 weeks after the study to evaluate any condition related to the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Asians

• Diagnosed type 2 diabetes

• BMI between 25 and 40 kgm2

• Aged between 20 and 75 years old

• Current HbA1c between 6.0 and 8.5 percents

• Men and non-pregnant women. If woman, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control-condoms, sponge, foams, jellies, diaphragm or intrauterine device or on contraceptives for the 3-month period prior to Screening-a vasectomized partner-total abstinence from sexual intercourse. If woman, the results of a urine pregnancy test performed at Screening are negative. If woman, subject is not breast-feeding

• Subject is able and willing to replace breakfast and one snack before bed with Glucerna SR

• Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board or Independent Ethics Committee, prior to undertaking any study-specific procedures

Exclusion Criteria:

• History or evidence of type 1 diabetes

• Screening fasting glucose greater than 240 mgdL

• Treatment with insulin, alpha-glucosidase inhibitor, incretin mimetics, or DPP-IV inhibitors in the past 8 weeks

• History of severe hypoglycemia in the past 12 weeks

• History of severe diabetes complications e.g. amputation, blindness, diabetic coma

• Stated history of severe gastroparesis

• Stated significant cardiovascular event e.g., myocardial infarction, stroke within 6 weeks prior to study entry; or stated history of congestive heart failure

• Current use of glucocorticoid steroids with the exception of topical use.

• History of renal insufficiency serum creatinine greater than 1.4 mgdL for women and greater than 1.5 for men

• Subjects with the following laboratory values: hemoglobin less than 10 gdL, WBC less than 3000mL, platelet less than 100,000mL, ALT greater than 3x ULN, total bilirubin greater than 2x ULN

• Stated current severe hepatic disease

• History or evidence of alcoholism or drug abuse

• History or evidence of hyperthyroidism or hypothyroidism

• History of malignancy within the last 5 years

• Consumption of any investigational drug within 30 days prior to enrollment.

• Taking any herbals or dietary supplements during the past 8 weeks that could profoundly affect appetite, weight or glucose metabolism

• Voluntary or involuntary weight loss of greater than 7 percents body weight in past 8 week

• History of major eating disorders, such as anorexia nervosa or bulimia nervosa

• Allergy to Glucerna SR or its content

• History of mental incapacity or language barriers that may preclude adequate understanding or cooperation in the study

• Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Glucerna SR
Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with exchange-diet plan only will receive a meal plan like they have in the lead-in period.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Abbott

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes		24 weeks	No
Secondary	evaluate the efficacy and safety of a meal replacement program with Glucerna SR vs. an EDP based on the nutrition therapy recommendations from the ADA on anthropometric measurements, lipid profile, meal-related metabolic changes and quality of life		24 weeks	Yes