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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Nagaoka Red Cross Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT01568125
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: March 2012

March 29, 2012
March 30, 2012
January 2010
January 2014   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • BMI [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Calory of dietary intake [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Content of dietary intake [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Incretin-related Drugs on Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus
Effect of Incretin-related Drugs on Energy and Contents of Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus

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.).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
100 patients
Type 2 Diabetes Mellitus
Drug: Incretin-related drugs
DPP-IV inhibitors are administered via per os. GLP-L receptor agonists are administered via subcutaneous injections.
Other Name: If necessary, other hypoglycemic and insulin drugs
Incretin-related drugs
Intervention: Drug: Incretin-related drugs
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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01568125
6
No
Not Provided
Not Provided
Kyuzi Kamoi, Nagaoka Red Cross Hospital
Nagaoka Red Cross Hospital
Not Provided
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
Principal Investigator: Yoshiko Kontai, RD Universty of Niigata Prefecture
Principal Investigator: Kanako Inoue, RD Universty of Niigata Prefecture
Nagaoka Red Cross Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP