Type2 Diabetes Clinical Trial
— MdietOfficial title:
Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes
This study in T2D patients is undertaken to evaluate the effect of previously studied 3Meals Diet, high energy breakfast (Bdiet) with milk and dairy proteins (MBdiet) versus isocaloric diet with same meal distribution but with other sources of protein (OBdiet) overall postprandial glycemia (PPG), weight loss (WL), HbA1c, CG expression and on PPG, insulin, C-peptide, GLP-1, gut peptide YY (PYY), cholecystokinin (CCK), ghrelin, dipeptidyl peptidase-4 plasma activity (DPP-4) and appetite responses after high protein breakfast. challenge including milk and dairy products (MBdiet) and after breakfast challenge with same protein content but different source of protein (OBdiet)
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | October 20, 2019 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with T2D < 20 years; - HgA1c = 7.0 %. - BMI - 28-40 kg/m2 - Men and women 30 -75 years of age inclusive. - Normal liver, kidney and thyroid functions, negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2. - Type 2 diabetes controlled with diet and lifestyle alone or with antidiabetic treatment other than insulin (i.e. buguanides, sulfonylureas, glinides, SGLT2 inhibitors, DPP4 inhibitors, GLP-1 analogs), with stable doses for at least 3 months before entering the study. - Stable weight (less than 5% change in body weight in last 3 months before the study - determined by self-reporting or documentation in clinical records). - Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs will be allowed also on stable dose for at least 3 months before the beginning of the trial. - Patients that usually wake up between 06:00 and 08:00 and go to sleep between 22:00 and 24:00. - Should not have shift work within 6 month of the study and should not have crossed time zones within 2 weeks of the study. Exclusion Criteria: - Type 1 diabetes or secondary forms of diabetes. - Patients with latent autoimmune diabetes in adults (LADA). - Treatment with insulin. - Serum creatinine level >2mg/dl. Renal dysfunction: (estimated glomerular filtration rate eGFR < 45 mL/min/1.73 m2). - Hepatic dysfunction: liver disease or transaminase levels > 2.5-fold above normal. Major illness with life expectancy < 5 years. - Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer). Those taking psychotropic, anorectic medication, steroid treatment or with illicit drug abuse or alcoholism within one year prior to study onset. Pregnancy or lactation. Known hypersensitivity to milk components or lactose intolerance. Night or rotating shift workers or those who crossed more than 2 time zones during the 2- week period prior to study onset. No change in medication or nutrition supplements or physical activity will be made during the study. Not able to give informed consent |
Country | Name | City | State |
---|---|---|---|
Israel | Daniela Jakubowicz | Holon | Wolfson Medical Center |
Israel | Diabetes Unit E. Wolfson Hospital | Holon | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel Aviv University | Shani Tsameret, Zohar Landau |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clock genes mRNA expression | The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing the clock genes expression | two weeks | |
Secondary | Continuous Glucose Monitoring (CGM) | The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing overall glycemia assessed by Continuous Glucose Monitoring (CGM) | two weeks | |
Secondary | HbA1c | The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing HbA1c | 3 months | |
Secondary | Body Weight | The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing body weight | 3 months |
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