CompletedNot Applicable

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

Israel28 participantsStarted 2016-11

Plain-language 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

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Insulin Dose

Timeframe: Baseline, 2 week and at 12 weeks

Trial details

NCT IDNCT02709915

SponsorTel Aviv University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

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