NCT01568125

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.).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

4 years

First QC Date

March 29, 2012

Last Update Submit

March 30, 2012

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    one year

Secondary Outcomes (3)

  • BMI

    One year

  • Calory of dietary intake

    One year

  • Content of dietary intake

    One year

Study Arms (1)

Incretin-related drugs

Drug: Incretin-related drugs

Interventions

Incretin-related drugsDRUG

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
Incretin-related drugs

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients

You may qualify if:

  • Japanese patients with T2DM without incretin-based therapy, who participated to examine the energy and content of intake using questionnaire reported previously.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2085, Japan

Location

Related Publications (1)

  • 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).

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 2, 2012

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

JP(1)