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

The recruitment status of this study is unknown because the information has not been verified recently.
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
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Drug: Incretin-related drugs

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • HbA1c [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

100 patients

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01568125

Locations
Japan
Nagaoka Red Cross Hospital
Nagaoka, Niigata, Japan, 940-2085
Sponsors and Collaborators
Nagaoka Red Cross Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Kyuzi Kamoi, Investigator, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01568125     History of Changes
Other Study ID Numbers: 6
Study First Received: March 29, 2012
Last Updated: March 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014