N/A
Completed N=14
The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
Source: ClinicalTrials.gov NCT01997281 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal — 10.5; 10.5 pM x hr/L
Summary
The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal |
10.5; 10.5 | — |
| SECONDARY AUC of Plasma Total GIP Levels After Intake of the Study Meal |
— | — |
| SECONDARY AUC of Plasma Glucose Levels After Intake of the Study Meal |
— | — |
| SECONDARY AUC of Plasma Insulin Levels After Intake of the Study Meal |
— | — |
| SECONDARY AUC of Plasma Glucagon Levels After Intake of the Study Meal |
— | — |
| SECONDARY AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal |
— | — |
| SECONDARY AUC of Plasma Total GIP Levels After Lunch |
— | — |
| SECONDARY AUC of Plasma Glucose Levels After Lunch |
— | — |
| SECONDARY AUC of Plasma Insulin Levels After Lunch |
— | — |
| SECONDARY AUC of Plasma Glucagon Levels After Lunch |
— | — |
| SECONDARY AUC of Serum Free Fatty Acid Levels After Lunch |
— | — |
| SECONDARY AUC of Plasma Total GLP-1 Levels After Lunch |
— | — |
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes mellitus
- HbA1c 6.5~8.5%
- on life style modification or metformin monotherapy at the time of screening
Exclusion Criteria
- on sulfonylurea or insulin therapy at the time of screening
- allergy to wheat, flour, other cereals or nuts
- lactose intolerance
- pregnancy / lactation
Data sourced from ClinicalTrials.gov (NCT01997281). 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. Informational only — not medical advice.