Effect of Incretin-related Drugs on Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus

Overview

It is well known that incretin, particular GLP-1enhances satiety and reduces energy intake in controlling appetite and dietary in humans (Flint A, et al. Gutzwiller JP et al.). Recently, incretin-based therapy has been attracted a lot of interest (Hare KJ, Knop FK). However, it is not clear how the incretin-based therapy affects energy and content of dietary intake in patients with type 2 diabetes mellitus (T2DM). Previously, the investigators reported the amount of energy and content of dietary intake in type 2 diabetic Japanese patients with more than 10 years of long time duration after discovery using questionnaire (Inoue K et al.) and the patients were impaired a secretion of active GLP-1 (Kamoi et al). The investigators examine whether the incretin-based therapy effects on the energy and content of dietary intake in the same patients before and one year after administration of incretin-related drugs using the same method previously (Inoue K et al.).

Full Title of Study: “Effect of Incretin-related Drugs on Energy and Contents of Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2014

Interventions

  • Drug: Incretin-related drugs
    • DPP-IV inhibitors are administered via per os. GLP-L receptor agonists are administered via subcutaneous injections.

Arms, Groups and Cohorts

  • Incretin-related drugs

Clinical Trial Outcome Measures

Primary Measures

  • HbA1c
    • Time Frame: one year

Secondary Measures

  • BMI
    • Time Frame: One year
  • Calory of dietary intake
    • Time Frame: One year
  • Content of dietary intake
    • Time Frame: One year

Participating in This Clinical Trial

Inclusion Criteria

  • Japanese patients with T2DM without incretin-based therapy, who participated to examine the energy and content of intake using questionnaire reported previously. Exclusion Criteria:

  • Patients with a serious complication in the heart, liver or kidney – Pregnant or possibly pregnant patients or lactating patients – Patients complicated with a malignant tumor at present. – Patients participating in other clinical study. – Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nagaoka Red Cross Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kyuzi Kamoi, Investigator – Nagaoka Red Cross Hospital
  • Overall Official(s)
    • Kyuzi Kamoi, MD, Principal Investigator, Nagaoka Red Cross Hospital
    • Yoshiko Kontai, RD, Principal Investigator, Universty of Niigata Prefecture
    • Kanako Inoue, RD, Principal Investigator, Universty of Niigata Prefecture

Citations Reporting on Results

1. Flint A, et al. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998; 101(3):515-520. 2. Gutzwiller JP, et al. Glucagon-like peptide-1: a potent regulator of food intake in humans. Gut. 1999; 44(1):81-86. 3. Verspohl EJ. Novel therapeutics for type 2 diabetes: incretin hormone mimetics (glucagon-like peptide-1 receptor agonists) and dipeptidyl peptidase-4 inhibitors. Pharmacol Ther. 2009; 124(1):113-38. 4. Hare KJ, Knop FK. Incretin-based therapy and type 2 diabetes. Vitam Horm. 2010; 84:389-41 5. Inoue K, Kontai Y, Kamoi K, et al. Energy and content of dietary intake and life related habituation using questionnaire written by Japanese language in Japanese patients with endocrine and metabolism disorders. Abstract in 14 Annual Scientific Meeting of the Metabolism and Clinical Nutrition Society, held at Yokohama of Japan on15th Jan, 2011 (in Japanese).

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