NCT05066152

Brief Summary

Recent studies indicate that dysbiosis of intestinal microbiota and low grade inflammation are important pathogenic determinants of type 2 diabetes (T2DM), which has increased in epidemic size over the last 20 years. Probiotics have been used in T2DM for the modification of IM and anti-inflammatory effects. However, effect of probiotics on metabolic control in T2DM are inconsistent. Present study will be designed to determine the effects of Lactobacillus GG (LGG) on glycemic control, lipid profile, inflammation parameters and expression of certain genes linked to T2DM. This study will be conducted at the Istanbul Faculty of Medicine, a tertiary care diabetes outpatient clinic and should involve 34 T2DM subjects. Subjects will be randomly assign to receive either LGG probiotic drop or a placebo.In this placebo controlled trial, effect of single strain probiotic vs. placebo on metabolic control and certain genes linked to T2DM will be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

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

Timeline
Completed

Started Feb 2016

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

Study Start

First participant enrolled

February 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

September 14, 2021

Last Update Submit

September 23, 2021

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2Lactobacillus GGprobioticgene expression

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    HbA1c %

    8 weeks compared to baseline

  • HOMA-IR

    HOMA-IR= Fasting plasma glucose (mg/dL) x Fasting plasma insulin (μU/mL)/405

    8 weeks compared to baseline

Secondary Outcomes (32)

  • QUICKI

    8 weeks compared to baseline

  • Fasting plasma glucose

    8 weeks compared to baseline

  • Fructosamine

    8 weeks compared to baseline

  • HDL-C

    8 weeks compared to baseline

  • LDL-C

    8 weeks compared to baseline

  • +27 more secondary outcomes

Study Arms (2)

Probiotic

EXPERIMENTAL

For 8 weeks of interventional period, the patient received 10 probiotic drops (1x1010 Cfu LGG) once daily at breakfast.

Dietary Supplement: Lactobacillus rhamnosus GG (ATCC 53103)

Placebo

PLACEBO COMPARATOR

For 8 weeks of interventional period, the patient received 10 probiotic drops (placebo) once daily at breakfast.

Dietary Supplement: Placebo

Interventions

Lactobacillus rhamnosus GG (ATCC 53103)DIETARY_SUPPLEMENT

One probiotic drop contained a formulation of 1x109 Cfu Lactobacillus rhamnosus GG (LGG; ATCC 53103)

Probiotic
PlaceboDIETARY_SUPPLEMENT

Carrier material of probiotic product, not containing bacterial strain, similar appearance as the probiotic

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Type 2 Diabetes
  • Taking oral-antidiabetic medication

You may not qualify if:

  • Smokers,
  • Alcohol drinkers,
  • Inflammatory bowel or autoimmune disease,
  • Immunodeficiency,
  • Using anti-epileptic, incretin enhancer (DPP-4 inhibitor), insulin or insulin analogs, dietary supplements
  • Breast-feeding or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Eliuz Tipici B, Coskunpinar E, Altunkanat D, Cagatay P, Omer B, Palanduz S, Satman I, Aral F. Lactobacillus GG is associated with mucin genes expressions in type 2 diabetes mellitus: a randomized, placebo-controlled trial. Eur J Nutr. 2023 Aug;62(5):2155-2164. doi: 10.1007/s00394-023-03139-3. Epub 2023 Mar 30.

    PMID: 36997822DERIVED

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
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective, single center, interventional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietician, Ph.D.

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 4, 2021

Study Start

February 1, 2016

Primary Completion

July 30, 2017

Study Completion

October 2, 2017

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share