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Trial record 26 of 395 for:    PYY

Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D (Mdiet)

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ClinicalTrials.gov Identifier: NCT03772067
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Zohar Landau
Shani Tsameret
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University

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 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)

Condition or disease Intervention/treatment Phase
Type2 Diabetes Healthy Obesity, Metabolically Device: Continuous glucose monitoring CGM Diagnostic Test: Clock Genes m RNA expression Diagnostic Test: Postprandial Glucose Diagnostic Test: Postprandial Insulin Diagnostic Test: Plasma GLP-1 Diagnostic Test: DPP4 plasma activity Diagnostic Test: Ghrelin Diagnostic Test: Plasma CCK Diagnostic Test: Plasma PYY Other: Body Weight Diagnostic Test: Blood levels of HbA1c Not Applicable

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 insulin and glucagon-like peptide-1 (GLP-1), are controlled by circadian clock genes (CG). However, the CG regulation is bidirectional, indeed high protein breakfast (B), by increasing insulin and GLP-1 upregulate CG expression leading to reduced overall PPG, HbA1c and weight loss (WL) in T2D. Furthermore in recent study the investigators have shown that in type 2 diabetic patient treated with insulin a diet with 3 Meal Diet consisting in high energy and protein breakfast, medium sized lunch and low energy dinner, with selective time restriction from carbohydrate consumption after 15:00, designed as Bdiet; was more effective approach for reduction of overall PPG, HbA1c and for upregulation of Clock Genes (CG) mRNA expression compared to isocaloric 6 Meal Diet, with calories and macronutrient evenly distributed along the day in three main meals and 3 snack in between.

As the beneficial effects of high energy and protein breakfast in 3Meal diet on the reduction of body weight, overall glycemia and up regulation CG expression, have been demonstrated, in recent studies, we hypothesized that some sources of protein in the breakfast may exert be more beneficial than other source of protein on body weight, PPG, HbA1c and on CG expression Milk consumption is linked to lower risk for obesity and T2D. In acute studies, the addition of milk to carbohydrates in B, displayed greater lowering effect of glucose response after breakfast, lunch and dinner compared with other protein sources.

However the effect of a diet 3Mdiet with high energy and dairy protein breakfast (MBdiet), on overall PPG, weight loss HbA1c, the effect on effect on circadian clock genes and AMPK mRNA expression and on the postprandial glucose, insulin, C-peptide, GLP-1, PYY, CCK, ghrelin, DPP4 plasma activity and appetite has never been explored and never were compared to isocaloric 3Mdiet with other then dairy protein source of protein (OBdiet) in long term study in T2D individuals .

The investigators hypothesize that a diet with high energy and protein breakfast consisting on milk and dairy proteins (MBdiet), by enhancing clock gene expression will lead to more efficient weight loss reduction of overall PPG, and glucose control (HbA1c), compared to a diet with other (non dairy) proteins in the breakfast (OBdiet). The investigators also hypothesize that the dairy breakfast effects in MBdiet may be mediated, at least in part, by integration of events that promote greater postprandial glucose insulin, C-peptide, GLP-1, PYY, and CCK, and greater suppression of ghrelin appetite and DPP4 plasma activity,


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes
Estimated Study Start Date : December 28, 2018
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBdiet
This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will contain 38 g protein mostly from milk and dairy products.
Device: Continuous glucose monitoring CGM
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention
Other Name: CGM

Diagnostic Test: Clock Genes m RNA expression
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention
Other Name: CG

Diagnostic Test: Postprandial Glucose
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention
Other Name: PPG

Diagnostic Test: Postprandial Insulin
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention
Other Name: Insulin

Diagnostic Test: Plasma GLP-1
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention
Other Name: GLP-1

Diagnostic Test: DPP4 plasma activity
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention
Other Name: DPP4

Diagnostic Test: Ghrelin
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention

Diagnostic Test: Plasma CCK
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention
Other Name: CCK

Diagnostic Test: Plasma PYY
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention
Other Name: PYY

Other: Body Weight
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention
Other Name: Weight

Diagnostic Test: Blood levels of HbA1c
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention
Other Name: HbA1c

Active Comparator: OBdiet
This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will 38 g protein without milk or dairy products mostly from other proteins, i.e. eggs, tuna, soy, oatmeal. Milk product will be avoided in this diet also in other meals along the day.
Device: Continuous glucose monitoring CGM
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention
Other Name: CGM

Diagnostic Test: Clock Genes m RNA expression
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention
Other Name: CG

Diagnostic Test: Postprandial Glucose
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention
Other Name: PPG

Diagnostic Test: Postprandial Insulin
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention
Other Name: Insulin

Diagnostic Test: Plasma GLP-1
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention
Other Name: GLP-1

Diagnostic Test: DPP4 plasma activity
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention
Other Name: DPP4

Diagnostic Test: Ghrelin
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention

Diagnostic Test: Plasma CCK
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention
Other Name: CCK

Diagnostic Test: Plasma PYY
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention
Other Name: PYY

Other: Body Weight
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention
Other Name: Weight

Diagnostic Test: Blood levels of HbA1c
The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention
Other Name: HbA1c




Primary Outcome Measures :
  1. Clock genes mRNA expression [ Time Frame: two weeks ]
    The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing the clock genes expression


Secondary Outcome Measures :
  1. Continuous Glucose Monitoring (CGM) [ Time Frame: two weeks ]
    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)

  2. HbA1c [ Time Frame: 3 months ]
    The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing HbA1c

  3. Body Weight [ Time Frame: 3 months ]
    The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing body weight



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772067


Contacts
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Contact: DANIELA JAKUBOWICZ, MD +972508105552 daniela.jak@gmail.com
Contact: Julio Wainstein, MD +972506296940 vainstein@wolfson.health.gov.il

Locations
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Israel
Diabetes Unit E. Wolfson Hospital
Holon, Tel Aviv, Israel, 58100
Daniela Jakubowicz
Holon, Wolfson Medical Center, Israel, 58100
Sponsors and Collaborators
Tel Aviv University
Zohar Landau
Shani Tsameret

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Responsible Party: Daniela Jakubowicz, Professor, Tel Aviv University
ClinicalTrials.gov Identifier: NCT03772067     History of Changes
Other Study ID Numbers: 0226-17-WOMC
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Weight Loss
Obesity, Metabolically Benign
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Insulin
Insulin, Globin Zinc
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists