Diabetes Mellitus, Obesity
Conditions
Keywords
Diet, Incretins, Gastrointestinal Hormones, Fish Proteins
Brief summary
The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.
Interventions
DIETARY_SUPPLEMENTHigh-protein diet
The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal. A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.
DIETARY_SUPPLEMENTStandard diet
The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.
Sponsors
Jeju National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus * Subjects signed a written informed consent form
Exclusion criteria
* Liver cirrhosis * Chronic renal disease (serum creatinine \> 2mg/dL) * Severe congestive heart failure * Significant infectious or inflammatory diseases * intractable malignant neoplasm * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
| Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
| Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
| Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
| Difference in the iAUC for insulin after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
| Difference in the iAUC for C-peptide after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
| Difference in the iAUC for glucagon after food ingestion between high-protein and standard diet groups | 3 hours | Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced. |
Countries
South Korea
Outcome results
None listed