Type1 Diabetes MellitusNCT03766334
Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus
A study testing Highland Barley Diet in people with Type1 Diabetes Mellitus, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Highland Barley Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
Wuhan, Hubei
About this study
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.
Read the 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
- Being tested
- Highland Barley Diet
- Keywords
- Highland Barley Diet, Glucose variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highland Barley DietDietary supplement
Highland Barley Diet(20g, thrice-daily)
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Diet+Highland Barley Diet | Experimental | Diabetes Diet+Highland Barley Diet(20g, thrice-daily) Receives: Dietary Supplement: Highland Barley Diet |
| Diabetes Diet | No intervention | only Diabetes Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 12-week endpoint
Secondary outcomes (6)
Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline)
Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose control in patients with type 1 diabetes.
Measured: from baseline to 12-week endpoint
insulin dose(endpoint)-insulin dose(baseline)
Objective to investigate the effect of combination diabetes diet and highland barley diet on insulin dose in patients with type 1 diabetes.
Measured: from baseline to 12-week endpoint
Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline)
Objective to investigate the effect of combination diabetes diet and highland barley diet on life quality in patients with type 1 diabetes.
Measured: from baseline to 12-week endpoint
Body mass index(endpoint)-Body mass index(baseline)
Objective to investigate the effect of combination diabetes diet and highland barley diet on BMI in patients with type 1 diabetes.
Measured: from baseline to 12-week endpoint
beta-cell function at endpoint and baseline
Objective to investigate the effect of combination diabetes diet and highland barley diet on beta-cell function in patients with type 1 diabetes.
Measured: from baseline to 12-week endpoint
Waist circumference(endpoint)-Waist circumference(baseline)
Objective to investigate the effect of combination diabetes diet and highland barley diet on waist circumference in patients with type 1 diabetes.
Measured: from baseline to 12-week endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start5 Dec 2018
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Project closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuefeng Yu, Huazhong University of Science and Technology
- Investigators
- xuefeng Yu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766334
- Sponsor's protocol ID
- TJ-T1DM-CGM-001
- Status last verified
- Mar 2024
- First submitted
- 2 Jul 2018
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03766334
- Acronym / sponsor ID
- TJ-T1DM-CGM-001
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- Highland Barley Diet, Glucose variability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Diet+Highland Barley Diet | Experimental | Dietary Supplement: Highland Barley DietDiabetes Diet+Highland Barley Diet(20g, thrice-daily) |
| Diabetes Diet | No intervention | –only Diabetes Diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highland Barley DietHighland Barley Diet(20g, thrice-daily) | Dietary supplement | Diabetes Diet+Highland Barley Diet |
Primary outcome
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.
6 secondary outcomes
Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline)
Time frame: from baseline to 12-week endpoint
insulin dose(endpoint)-insulin dose(baseline)
Time frame: from baseline to 12-week endpoint
Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline)
Time frame: from baseline to 12-week endpoint
Body mass index(endpoint)-Body mass index(baseline)
Time frame: from baseline to 12-week endpoint
beta-cell function at endpoint and baseline
Time frame: from baseline to 12-week endpoint
Waist circumference(endpoint)-Waist circumference(baseline)
Time frame: from baseline to 12-week endpoint
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xuefeng Yu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highland Barley Diet in people with Type1 Diabetes Mellitus, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average blood glucose fluctuations at endpoint and baseline (time frame: from baseline to 12-week endpoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.