This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment incretin-related drugs
Sponsor Nagaoka Red Cross Hospital
Start date January 2010
End date January 2014
Trial size 100 participants
Trial identifier NCT01568125, 6


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.).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
incretin-related drugs If necessary, other hypoglycemic and insulin drugs
DPP-IV inhibitors are administered via per os. GLP-L receptor agonists are administered via subcutaneous injections.

Primary Outcomes

time frame: one year

Secondary Outcomes

time frame: One year
Calory of dietary intake
time frame: One year
Content of dietary intake
time frame: One year

Eligibility Criteria

Male or female participants from 20 years up to 95 years old.

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

Additional Information

Official title Effect of Incretin-related Drugs on Energy and Contents of Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus
Principal investigator Kyuzi Kamoi, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Nagaoka Red Cross Hospital.