Clinical trial NCT02446054: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes Mellitus
Keywords: T2DM, type II diabetes Mellitus, HbA1c
Lead sponsor: Celio Technology Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: the change of glycosylated hemoglobin (HbA1c)
timeFrame: 12 weeks
Secondary outcomes:
measure: the change of patients' fasting blood Glucose
timeFrame: 12 weeks
measure: the change of patients' fasting serum Insulin
timeFrame: 12 weeks
measure: the change of patients' fasting serum C-peptide
timeFrame: 12 weeks
measure: the change of EuroQol EQ-5D questionnaire
timeFrame: 12 weeks
measure: the change of WHO-QoL questionnaire
timeFrame: 12 weeks
measure: the patients' compliance questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: NTUH
name: CY Wang
role: PRINCIPAL_INVESTIGATOR
References:
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.)