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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01568125
• Other study ID #: 6
• Status: Active, not recruiting
• Phase: N/A
• First received: March 29, 2012
• Last updated: March 30, 2012
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: March 2012
• Source: Nagaoka Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Japan	Nagaoka Red Cross Hospital	Nagaoka	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Nagaoka Red Cross Hospital

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		one year	Yes
Secondary	BMI		One year	Yes
Secondary	Calory of dietary intake		One year	Yes
Secondary	Content of dietary intake		One year	Yes