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Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA

ConditionsType 1 Diabetes MellitusAutoimmune Diabetes
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

7.0%≤HbA1c ≤10.0%;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Berberine

    Drug

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

  • Inulin

    Drug

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

  • Berberine placebo tablets

    Drug

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

  • Inulin placebo tablets

    Drug

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

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions
Group D: Group DPlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
1 year after start of trial

Secondary outcomes

1

Change in C-peptide

C-peptide are measured before and after a mixed meal tolerance test.

Time frame
1 year after start of trial
2

Incidence of acute and chronic diabetes complications

In this study, the chronic diabetes complications recorded mainly include diabetic macrovascular disease, diabetic nephropathy, diabetic retinopathy and peripheral neuropathy.

Time frame
1 year after start of trial
3

Change in gut permeability

Gut permeability is measured by amount of mannitol and lactulose in urine.

Time frame
1 year after start of trial
4

Change in gut microbiota composition

The changes of gut microbiota are mainly detected by multi omics technology.

Time frame
1 year after start of trial

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Xiangya Hospital of Central South University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: