Status:
UNKNOWN
Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D
Lead Sponsor:
Tel Aviv University
Collaborating Sponsors:
Zohar Landau
Shani Tsameret
Conditions:
Type2 Diabetes
Healthy Obesity, Metabolically
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Increased circadian glucose excursions and overall postprandial glycemia (PPG) are linked to HbA1c and cardiovascular risk in T2D. Most of the metabolic pathways involved in PPG i.e. secretion of ins...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03772067
Start Date
December 28 2018
End Date
October 20 2019
Last Update
December 11 2018
Active Locations (2)
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1
Diabetes Unit E. Wolfson Hospital
Holon, Tel Aviv, Israel, 58100
2
Daniela Jakubowicz
Holon, Wolfson Medical Center, Israel, 58100