NCT01939782

Brief Summary

This study is undertaken to explore whether compared to extension of overnight fast until lunch versus the breakfast consumption influence the oscillation of the metabolic clock gene expression in peripheral blood cells (PBC), at noon and after isocaloric lunch in type 2 diabetic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

September 2, 2013

Last Update Submit

April 20, 2015

Conditions

Type 2 Diabetes

Keywords

Metabolic CLock Genes (MCG)Type 2 Diabetes (T2D)

Outcome Measures

Primary Outcomes (1)

  • Metabolic Clock Gene Expression in Peripheral Blood Cells(PBC),

    In all subjects the the blood samples for metabolic clock gene expression in PBC will be evaluated in PBC in two different occasions Fasting No Breakfast (NoB): fasting until lunch at 12:00 Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00 In both occasions the blood samples for the clock genes will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch)

    Blood samples for the clock genes will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2h after lunch)

Secondary Outcomes (4)

  • Serum glucose insulin and intact GLP-1 levels

    Blood samples for glucose insulin and intact GLP-1 levels will be taken after overnight fast at 8:30 and then at 9:00, 10:30 , 12:00, 12:30, 14:00 and 15:30

  • Serum Triglycerides and Free Fatty Acids

    Blood samples for Triglycerides and Free Fatty Acids will be taken after overnight fast at 8:30 and then at 9:00, 10:30 , 12:00, 12:30, 14:00 and 15:30

  • DPP4 plasma activity

    Blood samples for DPP4 plasma activity will be taken after overnight fast at 8:30, before lunch at 12:00 and at 15:30

  • Serum Cortisol

    Blood samples for Cortisol will be taken after overnight fast at 8:30 and then at 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30

Study Arms (2)

Type 2 diabetic patients (T2D)

EXPERIMENTAL

In type 2 diabetic patients (T2D), the investigators will evaluate the metabolic clock gene expression in PBC and serum glucose, insulin, triglycerides, free fatty acids (FFA), cortisol intact GLP-1, triglycerides ,cortisol, plasma free fatty acids (FFA l and DPP4 plasma activity in two different occasions: 1. No Breakfast (NoB): fasting until lunch at 12:00 2. Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00 In both occasions the blood samples for glucose and insulin, cortisol and intact GLP-1 will be taken after overnight fast at 8:30 and thenat 8:30, 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30. The samples for clock genes and for DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch).

Other: No Breakfast (NoB)Other: Yes Breakfast (YesB)

Healthy No Diabetics

ACTIVE COMPARATOR

In healthy No Diabetics,: the investigators will evaluate the metabolic clock gene expression in PBC and serum glucose, insulin, triglycerides, free fatty acids (FFA), cortisol intact GLP-1, triglycerides ,cortisol, plasma free fatty acids (FFA l and DPP4 plasma activity in two different occasions: 1. No Breakfast (NoB): fasting until lunch at 12:00 2. Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00 In both occasions the blood samples for glucose and insulin, cortisol and intact GLP-1 will be taken after overnight fast at 8:30 and thenat 8:30, 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30. The samples for clock genes and for DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch).

Other: No Breakfast (NoB)Other: Yes Breakfast (YesB)

Interventions

No Breakfast (NoB)OTHER

In both occasions the blood samples for glucose and insulin, cortisol triglycerides and intact GLP-1 will be taken after overnight fast at 8:30 and thenat 8:30, 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30. The samples for clock genes and for DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch).

Also known as: NoB
Healthy No DiabeticsType 2 diabetic patients (T2D)
Yes Breakfast (YesB)OTHER

In both occasions the blood samples for glucose and insulin, cortisol, triglycerides and intact GLP-1 will be taken after overnight fast at 8:30 and then at 8:30, 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30. The samples for clock genes and for DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch).

Also known as: YesB
Healthy No DiabeticsType 2 diabetic patients (T2D)

Eligibility Criteria

Age26 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients
  • HbA1C \> 6.5%
  • Duration of diabetes: 0.5 to 30 years
  • Subjects ≥ 26 and ≤ 65 years of age
  • BMI: \> 26 kg/m2
  • All oral antidiabetic treatments and will be allowed, not insulin treatment
  • Normal liver and kidney function
  • Normal thyroid function
  • Stable physical activity pattern during the three months immediately preceding study
  • No metabolic disease other than diabetes
  • Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
  • Normal TSH and FT4 levels
  • No shift work within 5 years of the study
  • Did not cross time zones within 1 month of the study
  • Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
  • +14 more criteria

You may not qualify if:

  • Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
  • Type 1 diabetes
  • Treatment with Insulin
  • Serum creatinin level \> 1.5 mg/dl
  • Pregnancy or lactation
  • Illicit drug abuse or alcoholism
  • Subjects taking anoretic drugs during the month immediately prior to study
  • Subjects on steroid treatment
  • Subjects known by the principal investigator to be unable to cooperate for any reason.
  • Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
  • Night or rotating shift work
  • Jet lag during the 2 week period immediately prior to study onset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daniela Jakubowicz MD

Holon, N/A = Not Applicable, 58100, Israel

RECRUITING

Related Publications (1)

  • Jakubowicz D, Wainstein J, Landau Z, Raz I, Ahren B, Chapnik N, Ganz T, Menaged M, Barnea M, Bar-Dayan Y, Froy O. Influences of Breakfast on Clock Gene Expression and Postprandial Glycemia in Healthy Individuals and Individuals With Diabetes: A Randomized Clinical Trial. Diabetes Care. 2017 Nov;40(11):1573-1579. doi: 10.2337/dc16-2753. Epub 2017 Aug 22.

    PMID: 28830875DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daniela Jakubowicz, MD

    Diabetes Unit E. Wolfson Medical Center. Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Jakubowicz, MD

CONTACT

972508105552daniela.jak@gmail.com

Oren Froy, PhD

CONTACT

972546237664oren.froy@mail.huji.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Daniela Jakubowicz MD

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 11, 2013

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

IL(1)