Type 2 Diabetes Clinical Trial
— HPBOfficial title:
Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
Verified date | July 2016 |
Source | Hospital de Clinicas Caracas |
Contact | n/a |
Is FDA regulated | No |
Health authority | Venezuela: Ethics Committee |
Study type | Interventional |
The investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals
Status | Active, not recruiting |
Enrollment | 58 |
Est. completion date | October 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Subjects =30 and =70 years of age 2. BMI: 26 to 34 kg/m2) 3. Diabetes criteria 4. HbA1C: 7-9 % or 5. Habitually eat breakfast 6. Only naïve or treated with metformin. 7. Those with anti-hypertensive and lipid-lowering medication will be included. 8. . Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months 10.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation. 12. Normal liver, kidney and thyroid function. 13. Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) > 60 mL/min/1.73 m2. Exclusion Criteria: 1. Type 1 Diabetes 2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease 3. Anemia (Hg > 10 g/dL) 4. Serum creatinine level < 1.5 mg/dl 5. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery. 6. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate 7. Infectious disease 8. Malignancy 9. Pregnant women or lactating 10. Known hypersensitivity to milk components 10. Participating in dietary program or using of weight-loss medications 11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism. 12. Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Daniela Jakubowicz | Holon | N/A = Not Applicable |
Venezuela | Daniela Jakubowicz | Caracas | San Bernardino |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas Caracas | Tel Aviv University |
Israel, Venezuela,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma glucose | Postprandial plasma glucose after breakfast, lunch and dinner | 12 weeks | No |
Secondary | Plasma Insulin | Postprandial plasma insulin after breakfast lunch and dinner | 12 weeks | No |
Secondary | Hunger | Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale. | 12 weeks | No |
Secondary | Satiety | Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale. | 12 weeks | No |
Secondary | Change in body weight | Body weight will be assessed every every two weeks until week 12 | 12 weeks | No |
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