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Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03766334
Recruitment Status : Enrolling by invitation
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Xuefeng Yu, Huazhong University of Science and Technology

Brief Summary:

Approximately 80 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms:diabetes diet+highland barley diet; or diabetes diet.

Study treatment will continue for 12 weeks. The primary efficacy measure is the change in MAGE from continuous glucose monitoring system at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 8-day run-in period (period B) and a 12-week treatment period (period C). Continuous glucose monitoring system will be used in baseline and endpoint.


Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Dietary Supplement: Highland Barley Diet Not Applicable

Detailed Description:
This is a prospective, randomized, open-label comparison of the effects and safety of barley meal plus diabetes diet on blood glucose fluctuations in patients with type 1 diabetes (T1DM) using multiple daily insulin injections (MDI). , parallel test. About 80 patients with T1DM were enrolled in the preliminary trial. During the lead-in period, no interventions were given to the patient's diet from day 1 to day 4, and diabetes diet education and guidance were given from day 5 to day 8, depending on the patient's blood glucose and diet. Personalization of habits, weights, and activities, etc., establish a diabetes diet. At the end of the lead-in period, patients were randomly divided into two treatment groups according to the ratio of 1:1: Observation group: Diabetes diet + barley diet. (The barley meal group diet was formulated according to the diabetes diet, but each meal was replaced with 20g barley nutrition powder and other calories instead of part of the diet. In the control group: Diabetes diet; dietary treatment after randomization will continue for 12 weeks. From the induction period to the treatment period 6 days, treatment period 10-12 weeks

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus
Estimated Study Start Date : December 5, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Diabetes Diet+Highland Barley Diet
Diabetes Diet+Highland Barley Diet(20g, thrice-daily)
Dietary Supplement: Highland Barley Diet
Highland Barley Diet(20g, thrice-daily)

No Intervention: Diabetes Diet
only Diabetes Diet



Primary Outcome Measures :
  1. Average blood glucose fluctuations at endpoint and baseline [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose variability in insufficient control patients with type 1 diabetes.


Secondary Outcome Measures :
  1. Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline) [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose control in patients with type 1 diabetes.

  2. insulin dose(endpoint)-insulin dose(baseline) [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on insulin dose in patients with type 1 diabetes.

  3. Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline) [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on life quality in patients with type 1 diabetes.

  4. Body mass index(endpoint)-Body mass index(baseline) [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on BMI in patients with type 1 diabetes.

  5. beta-cell function at endpoint and baseline [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on beta-cell function in patients with type 1 diabetes.

  6. Waist circumference(endpoint)-Waist circumference(baseline) [ Time Frame: from baseline to 12-week endpoint ]
    Objective to investigate the effect of combination diabetes diet and highland barley diet on waist circumference in patients with type 1 diabetes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. type 1 diabetes patients with disease duration more than one year
  2. HbA1c ≥7.0 % and < 11.0 %
  3. Men and women (non-pregnant and using a medically approved birthcontrol method) aged ≥ 18 and ≤ 65 years
  4. BMI ≥ 18 and ≤ 26 kg/m2

Exclusion Criteria:

  1. Type 2 diabetes or other specific types of diabetes
  2. Pregnancy, preparation for pregnancy, lactation and women of childbearing age incapable of effective contraception methods
  3. Uncooperative subject because of various reasons
  4. Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal
  5. Impairment of renal function, serum creatinine: ≥ 133mmol/L for female,≥ 135mmol/L for male
  6. Serious chronic gastrointestinal diseases
  7. Edema
  8. Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
  9. Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
  10. White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L,or definite anemia (Hb:< 120g/L for male, < 110g/L for female), or other hematological diseases
  11. Endocrine system diseases, such as hyperthyroidism and hypercortisolism
  12. Experimental drug allergy or frequent hypoglycemia
  13. Psychiatric disorders, drug or other substance abuse
  14. Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
  15. Stressful situations such as surgery, serious trauma and so on
  16. Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
  17. Combined use of drugs effecting glucose metabolism such as glucocorticoid Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766334


Locations
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China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
Wuhan, Hubei, China
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Principal Investigator: xuefeng Yu Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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Responsible Party: Xuefeng Yu, Chief of Department of Endocrinology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03766334     History of Changes
Other Study ID Numbers: TJ-T1DM-CGM-001
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xuefeng Yu, Huazhong University of Science and Technology:
Highland Barley Diet
Glucose variability

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases