N/A
N=40
Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes
Patients With Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03727854 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in HbA1c From Baseline — 0.015; 0.030 % (HbA1c) — p=0.933
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Premeal protein enriched bar (Dietary_supplement); Dietary modification (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline |
0.015; 0.030 | 0.933 |
| SECONDARY Change in Fasting Blood Glucose Level From Baseline |
1.9; 1.6 | 0.971 |
| SECONDARY Change in Body Weight From Baseline |
0.21; 0.03 | 0.608 |
| SECONDARY Change in Waist Circumference From Baseline |
0.70; 0.15 | 0.617 |
| SECONDARY Change in Blood Triglyceride Level From Baseline |
-5.05; -1.30 | 0.823 |
| SECONDARY Change in Blood High-density Lipoprotein Level From Baseline |
-3.70; -5.05 | 0.740 |
| SECONDARY Change in Blood Low-density Lipoprotein Level From Baseline |
2.90; -0.70 | 0.551 |
| SECONDARY Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline |
-1.00; -0.46 | 0.652 |
| SECONDARY Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline |
-35.53; -13.9 | 0.639 |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03727854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.