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Status unknownNCT01568125Updated Apr 2, 2012

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

An observational study in Type 2 Diabetes Mellitus, sponsored by Nagaoka Red Cross Hospital. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 95 Years. Per ClinicalTrials.gov, last updated 2012-04-02.

Sponsored by Nagaoka Red Cross Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 95 Years
Sex
All
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Study 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.).

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Conditions studied

  • Type 2 Diabetes Mellitus
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 100 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Nagaoka Red Cross Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 95 Years
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • Incretin-related drugs

    Drug: Incretin-related drugs

Interventions

  • DrugIncretin-related drugs

    DPP-IV inhibitors are administered via per os. GLP-L receptor agonists are administered via subcutaneous injections.

    Also known as: If necessary, other hypoglycemic and insulin drugs

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What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: one year

Secondary outcomes

  1. BMI

    Time frame: One year

  2. Calory of dietary intake

    Time frame: One year

  3. Content of dietary intake

    Time frame: One year

07

Study locations

1 site
  • Nagaoka Red Cross Hospital
    Nagaoka, Niigata 940-2085, Japan
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References and documents

Publications

  • 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).
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01568125
Lead sponsor
Nagaoka Red Cross Hospital
Responsible party
Kyuzi Kamoi (Investigator, Nagaoka Red Cross Hospital) — Principal investigator
First posted
Apr 2, 2012
Start date
Jan 2010
Primary completion
Jan 2014 (estimated)
Completion
Jan 2014 (estimated)
Last update
Apr 2, 2012

Study contacts

Kyuzi Kamoi, MD
principal investigator · Nagaoka Red Cross Hospital
Yoshiko Kontai, RD
principal investigator · Universty of Niigata Prefecture
Kanako Inoue, RD
principal investigator · Universty of Niigata Prefecture

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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