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

Primary Purpose

Type II Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Musashino T2DM diet
Sponsored by
Celio Technology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type II Diabetes Mellitus focused on measuring T2DM, type II diabetes Mellitus, HbA1c

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NTUH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One Arm Study

Arm Description

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

Outcomes

Primary Outcome Measures

the change of glycosylated hemoglobin (HbA1c)
12 weeks diet control

Secondary Outcome Measures

the change of patients' fasting blood Glucose
the change of patients' fasting serum Insulin
the change of patients' fasting serum C-peptide
the change of EuroQol EQ-5D questionnaire
the change of WHO-QoL questionnaire
the patients' compliance questionnaire

Full Information

First Posted
May 13, 2015
Last Updated
January 27, 2016
Sponsor
Celio Technology Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02446054
Brief Title
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
Official Title
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celio Technology Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
T2DM, type II diabetes Mellitus, HbA1c

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One Arm Study
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Musashino T2DM diet
Intervention Description
provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
Primary Outcome Measure Information:
Title
the change of glycosylated hemoglobin (HbA1c)
Description
12 weeks diet control
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
the change of patients' fasting blood Glucose
Time Frame
12 weeks
Title
the change of patients' fasting serum Insulin
Time Frame
12 weeks
Title
the change of patients' fasting serum C-peptide
Time Frame
12 weeks
Title
the change of EuroQol EQ-5D questionnaire
Time Frame
12 weeks
Title
the change of WHO-QoL questionnaire
Time Frame
12 weeks
Title
the patients' compliance questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CY Wang
Organizational Affiliation
NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
NTUH
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
Citation
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.)
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A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease

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