NCT03766334

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Highland Barley Diet	Highland Barley Diet(20g, thrice-daily)

Timeline

• Start date: 2018-12-05
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2018-12-06
• Last updated: 2024-03-18

Locations

1 site across 1 country: China