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

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

Sponsors

Lead sponsor: Celio Technology Inc.

Source Celio Technology Inc.
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.

Overall Status Completed
Start Date February 2014
Completion Date December 2015
Primary Completion Date September 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the change of glycosylated hemoglobin (HbA1c) 12 weeks
Secondary Outcome
Measure Time Frame
the change of patients' fasting blood Glucose 12 weeks
the change of patients' fasting serum Insulin 12 weeks
the change of patients' fasting serum C-peptide 12 weeks
the change of EuroQol EQ-5D questionnaire 12 weeks
the change of WHO‐QoL questionnaire 12 weeks
the patients' compliance questionnaire 12 weeks
Enrollment 30
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Musashino T2DM diet

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.

Arm group label: One Arm Study

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

Gender: All

Minimum age: 30 Years

Maximum age: 60 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
CY Wang Principal Investigator NTUH
Location
facility NTUH
Location Countries

Taiwan

Verification Date

May 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: One Arm Study

Arm group type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov