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

• Sponsor: Celio Technology Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02446054
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 21.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus	Dietary Supplement: Musashino T2DM diet	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. the change of glycosylated hemoglobin (HbA1c) [12 weeks]

   12 weeks diet control

Secondary Outcome Measures

1. the change of patients' fasting blood Glucose [12 weeks]

2. the change of patients' fasting serum Insulin [12 weeks]

3. the change of patients' fasting serum C-peptide [12 weeks]

4. the change of EuroQol EQ-5D questionnaire [12 weeks]

5. the change of WHO-QoL questionnaire [12 weeks]

6. the patients' compliance questionnaire [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NTUH	Taipei		Taiwan

Sponsors and Collaborators

• Celio Technology Inc.

Investigators

• Principal Investigator: CY Wang, NTUH

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.)

• Responsible Party: Celio Technology Inc.
• ClinicalTrials.gov Identifier: NCT02446054
• Other Study ID Numbers: 2013CMP-V2
• First Posted: May 15, 2015
• Last Update Posted: Jan 28, 2016
• Last Verified: May 1, 2015

• Keywords provided by Celio Technology Inc.: T2DM, type II diabetes Mellitus, HbA1c
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 28, 2016