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NCT Number: NCT02446054

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

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

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NTUH

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Musashino T2DM diet

Dietary 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.

Primary outcomes

  1. the change of glycosylated hemoglobin (HbA1c)

    Time frame: 12 weeks

    12 weeks diet control

Secondary outcomes

  1. the change of patients' fasting blood Glucose

    Time frame: 12 weeks

  2. the change of patients' fasting serum Insulin

    Time frame: 12 weeks

  3. the change of patients' fasting serum C-peptide

    Time frame: 12 weeks

  4. the change of EuroQol EQ-5D questionnaire

    Time frame: 12 weeks

  5. the change of WHO-QoL questionnaire

    Time frame: 12 weeks

  6. the patients' compliance questionnaire

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Celio Technology Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 15, 2015
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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