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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01568125
Recruitment Status : Unknown
Verified March 2012 by Kyuzi Kamoi, Nagaoka Red Cross Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2012
Last Update Posted : April 2, 2012
Information provided by (Responsible Party):
Kyuzi Kamoi, 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.).

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Incretin-related drugs

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Incretin-related Drugs on Energy and Contents of Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus
Study Start Date : January 2010
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Incretin-related drugs 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

Primary Outcome Measures :
  1. HbA1c [ Time Frame: one year ]

Secondary Outcome Measures :
  1. BMI [ Time Frame: One year ]
  2. Calory of dietary intake [ Time Frame: One year ]
  3. Content of dietary intake [ Time Frame: One year ]

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100 patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01568125

Nagaoka Red Cross Hospital
Nagaoka, Niigata, Japan, 940-2085
Sponsors and Collaborators
Nagaoka Red Cross Hospital
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

Publications of 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).

Responsible Party: Kyuzi Kamoi, Investigator, Nagaoka Red Cross Hospital Identifier: NCT01568125     History of Changes
Other Study ID Numbers: 6
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs