Back to resultsMetabolic Clock Genes During Fasting and After Food Intake in Type 2 Diabetics (MCG-T2D)
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
No Breakfast (NoB)
Yes Breakfast (YesB)
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring Metabolic CLock Genes (MCG), Type 2 Diabetes (T2D)
Eligibility Criteria
Inclusion Criteria:
INCLUSION CRITERIA FOR PATIENTS WITH TYPE 2 DIABETES
- 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
- Read and understood the informed consent form and signed it voluntarily
INCLUSION CRITERIA FOR HEALTHY NON-DIABETIC PATIENTS
- Healthy non diabetic, and not known as diabetic
- Fating glucose <100 mg/dl
- HbA1C <5.7 %
- Not taking any antidiabetic drugs
- Subjects ≥ 26 and ≤ 65 years of age
- BMI: <26 kg/m2
- Normal liver and kidney function
- Normal TSH and FT4 levels
- Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
- No shift work within 5 years of the study
- Did not cross time zones within 1 month of the study
- Acceptable health based on interview, medical history, physical examination, and laboratory tests
- Read and understood the informed consent form and signed it voluntarily
Exclusion Criteria:
EXCLUSION CRITERIA FOR ALL 2 GROUPS (HEALTHY AND DIABETICS)
- 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
Sites / Locations
- Daniela Jakubowicz MDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Type 2 diabetic patients (T2D)
Healthy No Diabetics
Arm Description
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: 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 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).
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: 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 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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Serum glucose insulin and intact GLP-1 levels
In all subjects the the blood samples for serum glucose insulin and intact GLP-1 levels will be evaluated, in two different occasions:
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 glucose and insulin will be taken after overnight fast at 8:00 and then every hour until 15:30.
Serum Triglycerides and Free Fatty Acids
In all subjects the the blood samples for serum Triglycerides and Free Fatty Acids plasma levels will be evaluated, in two different occasions No Breakfast (NoB): fasting until lunch at 12:00 Yes Breakfast (YesB): eating breakfast at Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00
DPP4 plasma activity
In all subjects the the blood samples for DPP4 plasma activity will be evaluated in PBC in two different occasions 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 DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch)
Serum Cortisol
In all subjects the the blood samples for serum Cortisol will be evaluated, in two different occasions No Breakfast (NoB): fasting until lunch at 12:00 Yes Breakfast (YesB): eating breakfast at Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00 Yes Breakfast (YesB): eating breakfast at Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01939782
Brief Title
Metabolic Clock Genes During Fasting and After Food Intake in Type 2 Diabetics
Acronym
MCG-T2D
Official Title
Metabolic Clock Gene Expression in Peripheral Blood Cells During Fasting and After Food Intake in the Breakfast in Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Most of our metabolic function is controlled by metabolic clock genes that regulate glucose, lipid metabolism and several other circadian metabolic pathways involved in insulin resistance obesity and type 2 diabetes. The main group of clock genes resides in the SCN nuclei and is synchronized by light/dark signals. However similar clock oscillators called peripheral clocks are found in almost all tissues, including in the liver, heart, kidney, intestine, skeletal muscles, and adipocytes and in peripheral blood cells (PBC). The peripheral clocks, and specially those metabolic clock genes, seem to be controlled mainly by food cues.
The time of food intake synchronize simultaneously and in parallel way almost all the peripheral metabolic clock genes including those expressed and in peripheral blood cells (PBC) i.e. leucocytes, monocytes; allowing to explore the oscillation of the metabolic clock gene expression of the whole body by assessing its expression in the PBC. Impaired oscillation of the metabolic clock gene mRNA expression was found in diabetic animal models and in patients with type 2 diabetes and were inversely correlated with HbA1c.
In support of these finding we reported that high calorie breakfast with reduced dinner improved insulin sensitivity and weight loss rate among obese subjects, while in type 2 diabetic patients the high calorie breakfast was associated with improvement of HbA1c.
Moreover, recently was shown that very short time (only 120 min) after food intake in the breakfast, was sufficient to reset the expression of the circadian clock genes.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Metabolic CLock Genes (MCG), Type 2 Diabetes (T2D)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 2 diabetic patients (T2D)
Arm Type
Experimental
Arm Description
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:
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 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).
Arm Title
Healthy No Diabetics
Arm Type
Active Comparator
Arm Description
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:
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 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).
Intervention Type
Other
Intervention Name(s)
No Breakfast (NoB)
Other Intervention Name(s)
NoB
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Yes Breakfast (YesB)
Other Intervention Name(s)
YesB
Intervention Description
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).
Primary Outcome Measure Information:
Title
Metabolic Clock Gene Expression in Peripheral Blood Cells(PBC),
Description
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)
Time Frame
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 Outcome Measure Information:
Title
Serum glucose insulin and intact GLP-1 levels
Description
In all subjects the the blood samples for serum glucose insulin and intact GLP-1 levels will be evaluated, in two different occasions:
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 glucose and insulin will be taken after overnight fast at 8:00 and then every hour until 15:30.
Time Frame
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
Title
Serum Triglycerides and Free Fatty Acids
Description
In all subjects the the blood samples for serum Triglycerides and Free Fatty Acids plasma levels will be evaluated, in two different occasions No Breakfast (NoB): fasting until lunch at 12:00 Yes Breakfast (YesB): eating breakfast at Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00
Time Frame
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
Title
DPP4 plasma activity
Description
In all subjects the the blood samples for DPP4 plasma activity will be evaluated in PBC in two different occasions 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 DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch)
Time Frame
Blood samples for DPP4 plasma activity will be taken after overnight fast at 8:30, before lunch at 12:00 and at 15:30
Title
Serum Cortisol
Description
In all subjects the the blood samples for serum Cortisol will be evaluated, in two different occasions No Breakfast (NoB): fasting until lunch at 12:00 Yes Breakfast (YesB): eating breakfast at Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00 Yes Breakfast (YesB): eating breakfast at Yes Breakfast (YesB): eating breakfast at 8:30 and lunch at 12:00
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
INCLUSION CRITERIA FOR PATIENTS WITH TYPE 2 DIABETES
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
Read and understood the informed consent form and signed it voluntarily
INCLUSION CRITERIA FOR HEALTHY NON-DIABETIC PATIENTS
Healthy non diabetic, and not known as diabetic
Fating glucose <100 mg/dl
HbA1C <5.7 %
Not taking any antidiabetic drugs
Subjects ≥ 26 and ≤ 65 years of age
BMI: <26 kg/m2
Normal liver and kidney function
Normal TSH and FT4 levels
Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
No shift work within 5 years of the study
Did not cross time zones within 1 month of the study
Acceptable health based on interview, medical history, physical examination, and laboratory tests
Read and understood the informed consent form and signed it voluntarily
Exclusion Criteria:
EXCLUSION CRITERIA FOR ALL 2 GROUPS (HEALTHY AND DIABETICS)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Jakubowicz, MD
Phone
972508105552
Email
daniela.jak@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Oren Froy, PhD
Phone
972546237664
Email
oren.froy@mail.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Organizational Affiliation
Diabetes Unit E. Wolfson Medical Center. Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daniela Jakubowicz MD
City
Holon
State/Province
N/A = Not Applicable
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Phone
972508105552
Email
daniela.jak@gmail.com
First Name & Middle Initial & Last Name & Degree
Julio Wainstein, MD
Phone
972506296940
Email
vainstein@wolfson.health.gov.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
28830875
Citation
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.
Results Reference
derived
Learn more about this trial
Metabolic Clock Genes During Fasting and After Food Intake in Type 2 Diabetics
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