Patients With Type 2 Diabetes
Conditions
Keywords
protein-enriched bar, glycemic control, type 2 diabetes, long term
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPremeal protein enriched bar
Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).
BEHAVIORALDietary modification
Subjects in this group will follow diabetes diet education.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c From Baseline | 0 week, 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight From Baseline | 0 week, 12 weeks | — |
| Change in Waist Circumference From Baseline | 0 week, 12 weeks | — |
| Change in Blood Triglyceride Level From Baseline | 0 week, 12 weeks | — |
| Change in Fasting Blood Glucose Level From Baseline | 0 week, 12 weeks | — |
| Change in Blood Low-density Lipoprotein Level From Baseline | 0 week, 12 weeks | — |
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline | 0 week, 12 weeks | 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. |
| Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline | 0 week, 12 weeks | 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. |
| Change in Blood High-density Lipoprotein Level From Baseline | 0 week, 12 weeks | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group1 Premeal protein enriched bar with dietary modification
Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).
Dietary modification: Subjects in this group will follow diabetes diet education. | 20 |
| Group2 Dietary modification only
Dietary modification: Subjects in this group will follow diabetes diet education. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Group1 | Group2 | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 5.2 | 64.1 years STANDARD_DEVIATION 8.3 | 64.5 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized Korean | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in HbA1c From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in HbA1c From Baseline | 0.015 % (HbA1c) | Standard Deviation 0.706 |
| Group2 | Change in HbA1c From Baseline | 0.030 % (HbA1c) | Standard Deviation 0.354 |
p-value: 0.933t-test, 2 sided
Secondary
Change in Blood High-density Lipoprotein Level From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Blood High-density Lipoprotein Level From Baseline | -3.70 mg/dL | Standard Deviation 6.38 |
| Group2 | Change in Blood High-density Lipoprotein Level From Baseline | -5.05 mg/dL | Standard Deviation 16.91 |
p-value: 0.74t-test, 2 sided
Secondary
Change in Blood Low-density Lipoprotein Level From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Blood Low-density Lipoprotein Level From Baseline | 2.90 mg/dL | Standard Deviation 17.31 |
| Group2 | Change in Blood Low-density Lipoprotein Level From Baseline | -0.70 mg/dL | Standard Deviation 20.44 |
p-value: 0.551t-test, 2 sided
Secondary
Change in Blood Triglyceride Level From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Blood Triglyceride Level From Baseline | -5.05 mg/dL | Standard Deviation 50.74 |
| Group2 | Change in Blood Triglyceride Level From Baseline | -1.30 mg/dL | Standard Deviation 54.21 |
p-value: 0.823t-test, 2 sided
Secondary
Change in Body Weight From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Body Weight From Baseline | 0.21 kg | Standard Deviation 0.98 |
| Group2 | Change in Body Weight From Baseline | 0.03 kg | Standard Deviation 1.26 |
p-value: 0.608t-test, 2 sided
Secondary
Change in Fasting Blood Glucose Level From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Fasting Blood Glucose Level From Baseline | 1.9 mg/dL | Standard Deviation 26.2 |
| Group2 | Change in Fasting Blood Glucose Level From Baseline | 1.6 mg/dL | Standard Deviation 25.5 |
p-value: 0.971t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline | -1.00 units | Standard Deviation 5.11 |
| Group2 | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline | -0.46 units | Standard Deviation 1.67 |
p-value: 0.652t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline | -35.53 units | Standard Deviation 196.36 |
| Group2 | Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline | -13.9 units | Standard Deviation 58.4 |
p-value: 0.639t-test, 2 sided
Secondary
Change in Waist Circumference From Baseline
Time frame: 0 week, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group1 | Change in Waist Circumference From Baseline | 0.70 cm | Standard Deviation 3.73 |
| Group2 | Change in Waist Circumference From Baseline | 0.15 cm | Standard Deviation 3.15 |
p-value: 0.617t-test, 2 sided