Modification of Gut Microbiota in the Treatment of Insulin Resistance: a Personalized Approach

NCT03710850 | Completed

• 1 other identifier: NV18-01-00040
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Gut microbiota may play a key role in many metabolic diseases, including type 2 diabetes (T2D). Consumption of high-fat/high-sugar western diet seem to alter human resident microbiota towards reduced genetic diversity and to influence its metabolic activity towards enhanced energy extraction. Plant-based diets are effective in the treatment of T2D but it is not clear whether their effect results solely from diet composition or whether it is mediated, at least partly, by different microbiota and its metabolic activity. One possible therapeutic approach is replacement of "pro-diabetic" microbiota with its "healthy" variant but what the "healthy" microbiota is and under which conditions this microbiota could stay stable and functional is not known. The aim of the proposed study is to identify possible metagenome/metabolome characteristics in different human cohorts (T2D vs vegans), to assess the stability of vegan microbiota in T2D-like environment and to evaluate the possibility to influence human T2D microbiota/metabolome towards more protective composition by dietary intervention.

Conditions

Insulin Resistance; Microbiome

Keywords

Insulin resistance; Diabetes; Inulin; Microbiome

Outcome Measures

Primary Outcomes (2)

• Butyrate production

  Fecal butyrate content

  3 months

• Glucose disposal

  Rate of glucose disposal from 80IU insulin glucose clamp

  3 months

Secondary Outcomes (1)

• Suppression of lipolysis

  3 months

Study Arms (2)

Responders

EXPERIMENTAL

Responders in terms of fecal butyrate production after acute inulin test.

Dietary Supplement: Inulin

Non-responders

EXPERIMENTAL

Non-responders in terms of fecal butyrate production after acute inulin test.

Dietary Supplement: Inulin

Interventions

Inulin DIETARY_SUPPLEMENT

Inulin is a dietary fibre. Will be supplemented in a dose 10g/d for a period of 3 moths.

Non-responders; Responders

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overweight or obese volunteers (BMI over 25)

You may not qualify if:

• diabetes on medication
• any disease known to affect intestinal permeability
• antibiotic use less than 3 months prior to enrollment
• gravidity/lactation in women

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Institute for Clinical and Experimental Medicine: collaborator

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 10084, Czechia

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus

Interventions

Inulin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Jan Gojda, MD, PhD

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of unit

Model Details: single groups assignment

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: May 1, 2018
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)