Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes

Seoul National University Hospital40 enrolled

Overview

The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.

Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Patients With Type 2 Diabetes

Interventions

Premeal protein enriched barDIETARY_SUPPLEMENT

Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).

Dietary modificationBEHAVIORAL

Subjects in this group will follow diabetes diet education.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 18.5\~35 kg/m2 * Type 2 diabetes patients * Fasting blood glucose ≥ 126 mg/dl or * HbA1c ≥ 6.5% or * Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin. Exclusion Criteria: * HbA1c \< 6.5% or \> 10% * Subjects using insulin other than basal insulin * Subjects who have newly started or have changed anti diabetic drugs within 3 months * Subjects who are allergic to grains, nuts, legumes and milk * Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery) * Subjects with chronic unstable disease * Subjects with cognitive impairments who are not able to follow the study protocol * Females who are pregnant or doing breast feeding * Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges * Subjects with hemoglobin level of less than 10.0 g/dL * Subjects with alcohol addiction or drug abuse

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change in HbA1c From Baseline

Time frame: 0 week, 12 weeks

Secondary Outcomes

Change in Fasting Blood Glucose Level From Baseline

Time frame: 0 week, 12 weeks

Change in Body Weight From Baseline

Time frame: 0 week, 12 weeks

Change in Waist Circumference From Baseline

Time frame: 0 week, 12 weeks

Change in Blood Triglyceride Level From Baseline

Time frame: 0 week, 12 weeks

Change in Blood High-density Lipoprotein Level From Baseline

Time frame: 0 week, 12 weeks

Change in Blood Low-density Lipoprotein Level From Baseline

Time frame: 0 week, 12 weeks

Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.

Time frame: 0 week, 12 weeks

Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.

Time frame: 0 week, 12 weeks

Data from ClinicalTrials.gov

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