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Effect of Meal Frequency and Timing on Insulin Dose and Clock Gene in Type 2 Diabetic Patients (Bdiet-6Mdiet)

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ClinicalTrials.gov Identifier: NCT02709915
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University

Brief Summary:
This study is undertaken to explore in patients with uncontrolled T2D treated with insulin, whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first end point), compared to an isocaloric diet with 6 small meals distributed evenly along the day

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Breakfast Diet (Bdiet) Other: 6Meal Diet (6Mdiet Not Applicable

Detailed Description:

Obese patients with type 2 diabetes (T2D) and insulin resistance (IR), often require sequential increments of total daily insulin dose (TDID). This causes weight gain, worsens IR, leading to further increase of TDID and persistent hyperglycemia. In these patients, weight loss (WL) and reduction of IR are mandatory in order to achieve glucose control with less TDID. Impaired clock gene (CG) expression is linked to obesity and IR in T2D and it was shown in animals and T2D patients treated with oral anti-hyperglycemic drugs, that WL diet with restricted meal timing to specific hours, restored CG expression and was more effective for WL and for reduction of hyperglycemia compared to isocaloric WL diet, (commonly recommended for T2D), consisting of small meals randomly distributed along the day.

The investigators hypothesized that in patients with uncontrolled T2D treated with insulin, a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for WL and for achieving glycemic control and reduction of TDID, compared to an isocaloric diet with 6 small meals distributed evenly along the day (6Mdiet).

This will be a randomized parallel, open label clinical study. Thirty overweight and obese insulin-treated T2D patients with HbA1c>7.5% will be assigned to 12 weeks of 2 isocaloric diets: either Bdiet or 6Mdiet. HbA1c and CG mRNA expression in white blood cells and overall daily glycemia measured during 14 days, will be assessed before diet, after 14 days and at the end of the diet intervention. The TDID (first end point ) will be adjusted by physician, according to the results of self-monitoring of blood glucose on 3 consecutive days at baseline and before each of the visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Meal Frequency and Timing on Glycemic Control, Daily Insulin Dose Requirements and Clock Gene Expression in Uncontrolled Type 2 Diabetic Patients
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Breakfast Diet (Bdiet)
The Bdiet will consist in 3 meals with distribution of calories: breakfast 50%, lunch 33% and dinner 17%.
Other: Breakfast Diet (Bdiet)
The Breakfast Ddiet consist of high-energy breakfast, medium-sized lunch and reduced in energy dinner, with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. In this diet, the investigators will evaluate at baseline and at the end of 12 weeks of diet intervention, the diet efficacy on reducing HbA1c, the total daily insulin dose requirements (TDID), the efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion assessed with continuous monitoring system. The investigators will assess also the Clock Genes mRNA expression in white blood cells. at baseline and after 12 weeks of diet intervention
Other Name: Bdiet

Other: 6Meal Diet (6Mdiet
The 6meal diet (6Mdiet) will consist in the traditional antidiabetic diet, consuming 6 small meals: breakfast, lunch and dinner and 3 snacks, with caloric distribution: breakfast 20%, lunch 25%, dinner 25% and 10% each of the 3 snacks. In this diet, the investigators will evaluate at the beginning and at the end of the study (12 weeks), the diet effects on reducing HbA1c, total daily insulin dose requirements (TDID), and the diet efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion, using continuous monitoring system, The investigators will assess also at baseline and at the end of the diet intervention the Clock Genes mRNA expression in white blood cells.
Other Name: 6Mdiet

Active Comparator: 6 small meals diet (6Mdiet)
The 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% each of the three snacks.
Other: Breakfast Diet (Bdiet)
The Breakfast Ddiet consist of high-energy breakfast, medium-sized lunch and reduced in energy dinner, with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. In this diet, the investigators will evaluate at baseline and at the end of 12 weeks of diet intervention, the diet efficacy on reducing HbA1c, the total daily insulin dose requirements (TDID), the efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion assessed with continuous monitoring system. The investigators will assess also the Clock Genes mRNA expression in white blood cells. at baseline and after 12 weeks of diet intervention
Other Name: Bdiet

Other: 6Meal Diet (6Mdiet
The 6meal diet (6Mdiet) will consist in the traditional antidiabetic diet, consuming 6 small meals: breakfast, lunch and dinner and 3 snacks, with caloric distribution: breakfast 20%, lunch 25%, dinner 25% and 10% each of the 3 snacks. In this diet, the investigators will evaluate at the beginning and at the end of the study (12 weeks), the diet effects on reducing HbA1c, total daily insulin dose requirements (TDID), and the diet efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion, using continuous monitoring system, The investigators will assess also at baseline and at the end of the diet intervention the Clock Genes mRNA expression in white blood cells.
Other Name: 6Mdiet




Primary Outcome Measures :
  1. Insulin Dose [ Time Frame: Baseline, 2 week and at 12 weeks ]
    The effects of two diets (Bdiet and 6Mdiet) will be compared on their efficacy on total insulin dose reduction measured at baseline, after 2 weeks and at the end (12 weeks) of both diet interventions


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Baseline, 2 weeks and at 12 weeks ]
    The effect of the two diets (Bdiet and 6Mdiet) will be compared on the efficacy on the reduction of HbA1c measured at baseline, after 2 weeks and at the end (12 weeks) of both diet interventions

  2. Overall Glycemia [ Time Frame: Baseline, 2 week and at 12 weeks ]
    The effect of the two diets on all-day glycemia will be assessed with continuous blood monitoring system at baseline, after 2 weeks and after 12 weeks of the two diet intervention

  3. Clock Gene mRNA expression [ Time Frame: Baseline, 2 week and at 12 weeks ]
    The measurement of mRNA expression of clock gene in circulating white blood cells will be assessed at baseline, after 2 weeks and after 12 weeks of the two diet intervention


Other Outcome Measures:
  1. Body Weight [ Time Frame: Baseline, 2 week and at 12 weeks ]
    The measurement of body weight assessed at baseline, after 2 weeks and after 12 weeks of the two diet intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T2D patients with stable insulin 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.
  • Anti-hypertensive treatment will be allowed.
  • Lipid-lowering medication.

Exclusion Criteria

  • Type 1 diabetes.
  • Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
  • Presently dieting.
  • Change in weight of > 4.5 kg within 3 month prior to study onset.
  • Night or rotating shift workers.
  • Those who crossed more than 2 time zones during 2-week period prior to study onset.

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): NCT02709915


Locations
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Israel
Daniela Jakubowicz
Holon, Wolfson Medical Center, Israel, 58100
Sponsors and Collaborators
Tel Aviv University
Investigators
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Principal Investigator: Julio Wainstein, MD Wolfson Medical Center

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Responsible Party: Daniela Jakubowicz, Professor, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02709915    
Other Study ID Numbers: 0233-15-WOMC
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs