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

NCT03766334 | Withdrawn

• 1 other identifier: TJ-T1DM-CGM-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Keywords

Highland Barley Diet; Glucose variability

Outcome Measures

Primary Outcomes (1)

• Average blood glucose fluctuations at endpoint and baseline

  Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose variability in insufficient control patients with type 1 diabetes.

  from baseline to 12-week endpoint

Secondary Outcomes (6)

• Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline)

  from baseline to 12-week endpoint

• insulin dose(endpoint)-insulin dose(baseline)

  from baseline to 12-week endpoint

• Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline)

  from baseline to 12-week endpoint

• Body mass index(endpoint)-Body mass index(baseline)

  from baseline to 12-week endpoint

• beta-cell function at endpoint and baseline

  from baseline to 12-week endpoint

Study Arms (2)

Diabetes Diet+Highland Barley Diet

EXPERIMENTAL

Diabetes Diet+Highland Barley Diet(20g, thrice-daily)

Dietary Supplement: Highland Barley Diet

Diabetes Diet

NO INTERVENTION

only Diabetes Diet

Interventions

Highland Barley Diet DIETARY_SUPPLEMENT

Highland Barley Diet(20g, thrice-daily)

Diabetes Diet+Highland Barley Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 2 diabetes or other specific types of diabetes
• Pregnancy, preparation for pregnancy, lactation and women of childbearing age incapable of effective contraception methods
• Uncooperative subject because of various reasons
• Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \> twice the upper limits of normal
• Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
• Serious chronic gastrointestinal diseases
• Edema
• Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
• Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
• 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
• Endocrine system diseases, such as hyperthyroidism and hypercortisolism
• Experimental drug allergy or frequent hypoglycemia
• Psychiatric disorders, drug or other substance abuse
• Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
• Stressful situations such as surgery, serious trauma and so on

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology

Wuhan, Hubei, China

Location

Study Officials

• xuefeng Yu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Endocrinology

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: December 6, 2018
• Study Start: December 5, 2018
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)