NCT02446054

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

May 13, 2015

Last Update Submit

January 27, 2016

Conditions

Type II Diabetes Mellitus

Keywords

T2DM, type II diabetes Mellitus, HbA1c

Outcome Measures

Primary Outcomes (1)

  • the change of glycosylated hemoglobin (HbA1c)

    12 weeks diet control

    12 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

One Arm Study

EXPERIMENTAL

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

Interventions

Musashino T2DM dietDIETARY_SUPPLEMENT

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

One Arm Study

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, Taiwan

Location

Related 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.)

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • CY Wang

    NTUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 15, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2015-05

Locations

TW(1)