NCT03766308

Brief Summary

The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

October 29, 2017

Last Update Submit

August 30, 2021

Conditions

Type 2 Diabetes Mellitus

Keywords

highland barley diet

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    In the newly diagnosed type 2 diabetic patients, the absolute value of glycosylated hemoglobin from baseline to 12-week endpoints was compared between groups in the qingke diet group and the normal diet group.

    from baseline to 12-week endpoint

Secondary Outcomes (10)

  • The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%

    12 weeks

  • blood glucose

    6 weeks and 12weeks

  • Postprandial Blood Glucose

    6 weeks and 12weeks

  • 7 point self-monitoring blood sugar

    from baseline to 6 and 12 weeks

  • blood lipid

    from baseline to 6 and 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Highland barley diet

EXPERIMENTAL

highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)

Dietary Supplement: Highland Barley Diet

ADA diet

ACTIVE COMPARATOR

ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)

Dietary Supplement: ADA diet

Interventions

Highland Barley DietDIETARY_SUPPLEMENT

Highland Barley Diet

Highland barley diet
ADA dietDIETARY_SUPPLEMENT

ADA diet

ADA diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent
  • Type 2 diabetic patients （new diagnose ）
  • HbA1c ≥7.0 % and \< 9.0 % (HbA1c \> 7.0 % and ≤ 8.0% at randomization)
  • Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
  • BMI ≥ 23 and ≤ 35 kg/m2

You may not qualify if:

  • Type 1 diabetes or other specific types of diabetes
  • Pregnancy, preparation for pregnancy, lactation and women of child-bearing 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Department of Endocrinology

Study Record Dates

First Submitted

October 29, 2017

First Posted

December 6, 2018

Study Start

November 1, 2017

Primary Completion

October 30, 2020

Study Completion

December 31, 2020

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

CN(1)