Effect of Meal Timing in T2D on Hepatocytes SRIT1 and Clock Genes
Liver-CG
Effect Meal Timing in Type 2 Diabetes on Serum Induced SIRT1 and Clock Gene Expression in Hepatocytes
1 other identifier
interventional
24
1 country
1
Brief Summary
This study is undertaken to explore in T2D, the effect of meal timing on serum induced SIRT1 and Clock Genes mRNA expression in cultured hepatocytes. Fasting serum samples were collected from T2D participants, following two different meal timing schedules, either a diet with large breakfast and lunch with small dinner Breakfast Diet (3Mdiet) or an isocaloric diet with 6 small meals evenly distributed along the day Allday Diet (6Mdiet). The researchers will use an ex-vivo/in-vitro approach in which cultured medium will be conditioned with the fasted human serum collected from the two groups of T2D participants at baseline, after 2 weeks and after 12 week of the diet intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started May 2020
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
May 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2020
CompletedMay 28, 2020
May 1, 2020
4 months
May 19, 2020
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Clock Genes mRNA
Change from baseline serum-induced hepatocyte Clock Gene mRNA expression, will be assessed at 2 weeks post diet intervention in the two groups:Breakfast Diet (3Mdiet) and Allday Diet (6Mdiet)
Baseline and at 2 weeks post diet intervention
Secondary Outcomes (3)
Change in Clock Genes expression
Baseline and at 12 weeks post diet intervention
Change in SIRT1 mRNA expression
Baseline and at 2 weeks post diet intervention
Change in Overall Glycemia
Baseline and at 12 weeks post diet intervention
Study Arms (2)
Breakfast Diet (3Mdiet)
EXPERIMENTALThe Breakfast Diet (3Mdiet) will consist in 3 meals with distribution of calories: breakfast 50%, lunch 33% and dinner 17%.
Allday Diet (6Mdiet)
ACTIVE COMPARATORThe Allday Diet (6Mdiet) will consist on 6 meals (breakfast, lunch and dinner and 3 snacks) with distribution of calories: breakfast 15%, lunch 25%, dinner 30% and 10% in each of the three snacks.
Interventions
Breakfast Diet (3Mdiet) consist on high-energy breakfast and reduced in energy and carbohydrate (CH) dinner. Participants fasting serum to provide serum to for the in ex-vivo cell studies, will be collected at fasting (8:00), at start (day 0), after 2 weeks and at the end of 3Mdiet intervention (12 weeks). The participants serum is added to culture medium (as serum conditioned medium) to treat during 48 hours the cultured hepatocytes. After 48 hours of serum treatment, the mRNA extraction for the assessment of SIRT1 and Clock Gene expression will be performed at 00:00, 06:00, 12:00 and at 18:00 to assess SIRT1 and the Clock Genes circadian oscillation in hepatocytes. The 3Mdiet efficacy on reducing the overall glycemic excursions is assessed with continuous monitoring system at baseline after 2 weeks month of diet intervention.
Allday Diet (6Mdiet) consist in 6 small meals: breakfast, lunch and dinner and 3 snacks, with calories and carbohydrates (CH) evenly distributed throughout the day. Participants fasting serum to provide serum to for the in ex-vivo cell studies, will be collected at fasting (8:00), at start (day 0), after 2 weeks and at the end of 6Mdiet intervention (12 weeks). The participants serum is added to culture medium (as serum conditioned medium) to treat during 48 hours the cultured hepatocytes. After 48 hours of serum treatment, the mRNA extraction for the assessment of SIRT1 and Clock Gene expression will be performed at 00:00, 06:00, 12:00 and at 18:00 to assess SIRT1 and the Clock Genes circadian oscillation in hepatocytes. The 6Mdiet efficacy on reducing the overall glycemic excursions is assessed with continuous monitoring system at baseline after 2 weeks month of diet intervention.
Eligibility Criteria
You may qualify if:
- T2D patients with stable treatment for at least 3 month preceding the study.
- HgA1c \>7.5 %.
- Age \> 30 years.
- BMI: 27-34 kg/m2.
- Treatment with antidiabetic drugs (i.e. metformin, DPP4 inhibitors, glinides) and GLP-1 analogs, will be allowed
- Anti-hypertensive treatment will be allowed.
- Lipid-lowering medication also allowed
You may not qualify if:
- Type 1 diabetes.
- Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
- Change in weight of \> 4.5 kg within 3 month prior the diet onset.
- Night or rotating shift workers.
- Those who crossed more than 2 time zones during 2-week period prior to study onset.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wolfson Medical Center
Holon, Please Select, 58100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Jakubowicz, MD
Wolfson Medical Center
- PRINCIPAL INVESTIGATOR
Shani Tsameret, RD
E. Wolfson Medical Center.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Daniela Jakubowicz, MD: Clinical Profesor Head of Obesity Clinic at Diabetes Unit.
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 28, 2020
Study Start
May 31, 2020
Primary Completion
September 20, 2020
Study Completion
October 20, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05