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

Type II Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446054
• Other study ID #: 2013CMP-V2
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: January 27, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Celio Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Taiwan	NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Celio Technology Inc.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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.)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of glycosylated hemoglobin (HbA1c)	12 weeks diet control	12 weeks	No
Secondary	the change of patients' fasting blood Glucose		12 weeks	No
Secondary	the change of patients' fasting serum Insulin		12 weeks	No
Secondary	the change of patients' fasting serum C-peptide		12 weeks	No
Secondary	the change of EuroQol EQ-5D questionnaire		12 weeks	No
Secondary	the change of WHO-QoL questionnaire		12 weeks	No
Secondary	the patients' compliance questionnaire		12 weeks	No