A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease

NCT ID: NCT02446054

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

Brief Summary

Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control

Detailed Description

In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Conditions

Type II Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

One Arm Study

provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Group Type: EXPERIMENTAL

Musashino T2DM diet

Intervention Type: DIETARY_SUPPLEMENT

provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Interventions

Musashino T2DM diet

provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month
• The subject is able to understand and comply with protocol requirements, instrument
• The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess
• Signed and dated written informed consent

Exclusion Criteria

• Pregnancy, breastfeeding or planning to become pregnant during the study
• Acute illness or infection requiring treatment within 14 days of study entry
• Other serious disease (e.g. Heart, lung, brain, liver) within 3 months
• Presence of malignancies
• Participate in other clinical trial within 30 days prior to this study
• Alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator)
• Concurrent significant medical condition that would limit ability to participate in the study
• Consider by the investigator to be unsuitable for study participation, for any reason

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celio Technology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CY Wang

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

NTUH

Taipei, , Taiwan

Countries

Taiwan

References

1.Saydah SH, Eberhardt MS, Loria CM, Brancati FL. Age and the burden of death attributable to diabetes in the United States. Am J Epidemiol 2002;156:714-9. 2. Pastors JG, Franz MJ, Warshaw H, Daly A, Arnold MS. How effective is medical nutrition therapy in diabetes care? J Am Diet Assoc 2003;103:827-31. 3. American Diabetes Association, Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care 2008;31(Suppl 1):S61-78. 4. Robert E. Post, MD, MS, Arch G. Mainous III, PhD, Dana E. King, MD, MS, and Kit N. Simpson, DrPH Dietary Fiber for the Treatment of Type 2 Diabetes Mellitus: A Meta-Analysis J Am Board Fam Med 2012;25:16 -23.)

Reference Type: BACKGROUND

Other Identifiers

2013CMP-V2

Identifier Type: -

Identifier Source: org_study_id