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

Tel Aviv University

Status: Completed

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02709915

0233-15-WOMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Breakfast Diet (Bdiet)

Experimental group

Description:

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

Treatment:

Other: 6Meal Diet (6Mdiet

Other: Breakfast Diet (Bdiet)

6 small meals diet (6Mdiet)

Active Comparator group

Description:

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.

Treatment:

Other: 6Meal Diet (6Mdiet

Other: Breakfast Diet (Bdiet)