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

NCT02709915 | Completed

• 1 other identifier: 0233-15-WOMC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin Dose

  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

  Baseline, 2 week and at 12 weeks

Secondary Outcomes (3)

• HbA1c

  Baseline, 2 weeks and at 12 weeks

• Overall Glycemia

  Baseline, 2 week and at 12 weeks

• Clock Gene mRNA expression

  Baseline, 2 week and at 12 weeks

Other Outcomes (1)

• Body Weight

  Baseline, 2 week and at 12 weeks

Study Arms (2)

Breakfast Diet (Bdiet)

EXPERIMENTAL

The Bdiet will consist in 3 meals with distribution of calories: breakfast 50%, lunch 33% and dinner 17%.

Other: Breakfast Diet (Bdiet); Other: 6Meal Diet (6Mdiet

6 small meals diet (6Mdiet)

ACTIVE COMPARATOR

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); Other: 6Meal Diet (6Mdiet

Interventions

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

Also known as: Bdiet

6 small meals diet (6Mdiet); Breakfast Diet (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.

Also known as: 6Mdiet

6 small meals diet (6Mdiet); Breakfast Diet (Bdiet)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Daniela Jakubowicz

Holon, Wolfson Medical Center, 58100, Israel

Location

Related Publications (1)

• Jakubowicz D, Landau Z, Tsameret S, Wainstein J, Raz I, Ahren B, Chapnik N, Barnea M, Ganz T, Menaged M, Mor N, Bar-Dayan Y, Froy O. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care. 2019 Dec;42(12):2171-2180. doi: 10.2337/dc19-1142. Epub 2019 Sep 23.

  PMID: 31548244 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Julio Wainstein, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 16, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: February 1, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)