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

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Incretin-related drugs

• Registration Number: NCT01568125
• Lead Sponsor: Nagaoka Red Cross Hospital

Brief Summary

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.).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Last Update Submitted: 2012-03-30
• Study First Posted: 2012-04-02
• Last Update Posted: 2012-04-02
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incretin-related drugs	Incretin-related drugs	-

Primary Outcome Measures

Name	Time	Method
HbA1c	one year

Secondary Outcome Measures

Name	Time	Method
BMI	One year
Calory of dietary intake	One year
Content of dietary intake	One year

Trial Locations

Locations (1)

Nagaoka Red Cross Hospital; 🇯🇵 Nagaoka, Niigata, Japan