NCT04698330

Brief Summary

The primary purpose of this study is to evaluate the effects of oral berberine (BBR) and inulin combined with insulin therapy on diabetes care in patients with LADA.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
7mo left

Started May 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress88%
May 2022Dec 2026

First Submitted

Initial submission to the registry

January 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

January 2, 2021

Last Update Submit

February 8, 2022

Conditions

Type 1 Diabetes MellitusAutoimmune Diabetes

Keywords

LADABerberineInulinDiabetes Care

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    The primary outcome measure is the change in mean HbA1c level, reflecting the blood glucose management status of the patients.

    1 year after start of trial

Secondary Outcomes (7)

  • Change in C-peptide

    1 year after start of trial

  • Incidence of acute and chronic diabetes complications

    1 year after start of trial

  • Change in gut permeability

    1 year after start of trial

  • Change in gut microbiota composition

    1 year after start of trial

  • Assessment of quality of life

    1 year after start of trial

  • +2 more secondary outcomes

Study Arms (4)

Group A

EXPERIMENTAL

LADA patients are assigned to receive berberine and inulin for 3-month.

Drug: BerberineDrug: Inulin

Group B

EXPERIMENTAL

LADA patients are assigned to receive berberine and placebo(for inulin) for 3-month.

Drug: BerberineDrug: Inulin placebo tablets

Group C

EXPERIMENTAL

LADA patients are assigned to receive placebo(for berberine) and inulin for 3-month.

Drug: InulinDrug: Berberine placebo tablets

Group D

PLACEBO COMPARATOR

LADA patients are assigned to receive placebo(for berberine) and placebo(for inulin) for 3-month.

Drug: Berberine placebo tabletsDrug: Inulin placebo tablets

Interventions

BerberineDRUG

0.6g (6 pills) of Berberine tablets administered twice a day orally before meal for 3 months

Group AGroup B
InulinDRUG

0.6g (6 pills) of Inulin tablets administered twice a day orally before meal for 3 months

Group AGroup C
Berberine placebo tabletsDRUG

0.6g (6 pills) of Berberine placebo tablets administered twice a day orally before meal for 3 months

Group CGroup D
Inulin placebo tabletsDRUG

0.6g (6 pills) of Inulin placebo tablets administered twice a day orally before meal for 3 months

Group BGroup D

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes diagnosed according to the report of WHO in 1999；
  • Meet the Chinese Diabetes Society diagnostic criteria (2012) for LADA: (1)glutamic acid decarboxylase antibody (GADA) positive; (2) age at diagnosis ≧ 18 years old; (3) independent on insulin for more than 6 months after diagnosis;
  • Aged between 18 and 70 years old;
  • %≤HbA1c ≤10.0%;
  • BMI ≥ 18.5 kg/m2, and no more than 37.5 kg/m2;
  • Written informed consent from the patient or family representative.

You may not qualify if:

  • Severe liver dysfunction (ALT and AST greater than 3 times the upper limit of detection);
  • eGFR \< 50ml/(min • 1.73 m2);
  • Evidence of acute or chronic infection affecting glycemic control within 4 weeks prior to the first visit;
  • History of any malignancy;
  • Pregnancy, breastfeeding, or planned pregnancy during the study period;
  • Secondary diabetes;
  • Presence of acute complications (ketoacidosis, lactic acidosis or hyperosmolar coma);
  • Severe organic heart disease, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, etc., New York Heart Association (NYHA) heart function classification ≥Grade III;
  • Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months，or use of antibiotic medications or other interventions that could affect the gastrointestinal tract for 2 months before the screening and during the whole study period.
  • History of hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency.
  • Allergic to berberine or any components in the combinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (3)

  • Zhang Y, Gu Y, Ren H, Wang S, Zhong H, Zhao X, Ma J, Gu X, Xue Y, Huang S, Yang J, Chen L, Chen G, Qu S, Liang J, Qin L, Huang Q, Peng Y, Li Q, Wang X, Kong P, Hou G, Gao M, Shi Z, Li X, Qiu Y, Zou Y, Yang H, Wang J, Xu G, Lai S, Li J, Ning G, Wang W. Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). Nat Commun. 2020 Oct 6;11(1):5015. doi: 10.1038/s41467-020-18414-8.

    PMID: 33024120BACKGROUND

  • Ho J, Nicolucci AC, Virtanen H, Schick A, Meddings J, Reimer RA, Huang C. Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4427-4440. doi: 10.1210/jc.2019-00481.

    PMID: 31188437BACKGROUND

  • Zhang R, Xiao Y, Yan J, Yang W, Wu X, Mei Z, Zhou Z. Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: Protocol for a Randomized Controlled Trial. Front Endocrinol (Lausanne). 2022 Jun 15;13:876657. doi: 10.3389/fendo.2022.876657. eCollection 2022.

    PMID: 35784546DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

BerberineInulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Yang Xiao, MD/PhD

    Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Xiao, MD/PhD

CONTACT

86-731-85292154xiaoyang29@csu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 6, 2021

Study Start

May 1, 2022

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

CN(1)