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Completed

NCT Number: NCT02709915

Effect of Meal Frequency and Timing on Insulin Dose and Clock Gene in Type 2 Diabetic Patients

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daniela Jakubowicz

Holon, Wolfson Medical Center, 58100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breakfast Diet (Bdiet)

Other

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 names: Bdiet

6Meal Diet (6Mdiet

Other

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 names: 6Mdiet

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Effect of Meal Frequency and Timing on Glycemic Control, Daily Insulin Dose Requirements and Clock Gene Expression in Uncontrolled Type 2 Diabetic Patients

Acronym: Bdiet-6Mdiet

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Mar 16, 2016
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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