Type 2 Diabetes and the Effect of Probiotics

Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00413348

Enrollment

Registered

2006-12-19

Start date

2006-11-30

Completion date

2007-12-31

Last updated

2006-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotoxemia, Healthy, Type 2 Diabetes

Keywords

Type 2 diabetes, Probiotics, Insulin-resistance, Inflammation, Hyperinsulinemic euglycemic clamp, Endotoxin

Brief summary

Insulin-resistance in type 2 diabetes is associated with chronic inflammation. Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus NCFM might increase insulin-sensitivity. The inflammatory response to endotoxin injection and the insulin-sensitivity is examined before and after four weeks ingestion of probiotics.

Detailed description

Numerous studies have shown an association between insulin-resistance in type 2 diabetes and chronic low-grade inflammation. Some probiotics have an anti-inflammatory properties. Ingestion of probiotics might therefore, due to this property, increase sensitivity to insulin. In this study type 2 diabetics (N=24) and healthy control (N=24) are given the probiotic bacteria Lactobacillus Acidophilus NCFM for four weeks. The anti-inflammatory effect is examined by evaluating the inflammatory response (White blood cell count, plasma-cytokines) to an iv injection of endotoxin (0,3 ng/kg) before and after the intervention. Also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after L. acidophilus NCFM.

Interventions

DRUGLactobacillus acidophilus NCFM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

25 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy * Type 2 diabetes

Exclusion criteria

* Heart failure * Lung disease * Infections in the last two weeks before endotoxin injections. * Treatment with antibiotics

Design outcomes

Primary

Measure	Time frame
Change in insulin-resistance	—
Change in inflammatory response to E. coli endotoxin injection	—

Countries

Denmark

Contacts

Primary ContactAnne Sofie Andreasen, MD

sofie_andreasen@msn.com+45 3545 1616

Backup ContactBente K Pedersen, Preofessor

bkp@rh.dk+45 3545 7797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026