Human Faecal Microbiota in Type 2 Diabetes

NCT02694172 | Completed

• 1 other identifier: 06.42.NRC
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of the clinical trial is to investigate whether overweight type 2 diabetic patients have a different fecal microbiota profile compared with age, gender, BMI matched subjects and with lean healthy subjects before and after the consumption of fiber rich cereal bars.

Conditions

Type 2 Diabetes; Healthy; Overweight

Keywords

diabetes mellitus type 2; healthy subjects; human microbiome; cereal bar

Outcome Measures

Primary Outcomes (1)

• Fecal microbiota profile

  Fecal samples taken after the two week diet normalization are subjected to bacteria 16S rDNA sequencing and by quantitative PCR.

  Baseline samples taken after 2 weeks of diet normalization period

Secondary Outcomes (9)

• Metabonomic analysis in faeces

  Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable

• Metabonomic analysis in plasma

  Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

• Metabonomic analysis in urine

  Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

• Plasma glucose

  Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

• Plasma insulin

  Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

Study Arms (3)

Lean non diabetic

NO INTERVENTION

Lean and healthy subjects receiving no intervention

Overweight non diabetic

EXPERIMENTAL

fiber rich cereal bars, two bars a day for 4 weeks

Other: Fiber rich cereal bars

Overweight diabetic

EXPERIMENTAL

fiber rich cereal bars, two bars a day for 4 weeks

Other: Fiber rich cereal bars

Interventions

Fiber rich cereal bars OTHER

Two cereals per day and per subject for 4 weeks

Also known as: Nutren balance bars

Overweight diabetic; Overweight non diabetic

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ethnic background: Caucasian
• BMI: 25 to 40 kg/m2
• Fasting blood glucose \> 7 mmol/L
• Fasting Hemoglobin A1c \> 7%
• Consume mainly typical Western diets daily
• Having obtained his/her informed consent
• Ethnic background: Caucasian
• BMI: 20 to 25 kg/m2
• Fasting blood glucose \< 5.5 mmol/L
• Fasting Hemoglobin A1c \< 6 %
• Consume mainly typical Western diets daily
• Having obtained his/her informed consent

You may not qualify if:

• Diabetic and healthy (same BMI) subjects representing one or more of the following criteria are excluded from participation in the study.
• Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators
• People actively take cortisol or dexamethasone should be excluded from the study
• People under a-amylase/a-glucosidase inhibitors should be excluded from the study. However, patients under metformin can be accepted for this study.
• Patients under metformin suffering from gastrointestinal side effects within a 6-month time period prior to the trial
• Regular consumption of fermented dairy products
• Vegetarians
• Frequent diarrhea (more than two loose stool per day) within 7 days before the enrollment
• HIV seropositive
• Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, peptic ulcers and cancer
• Patients who cannot be expected to comply with treatment
• Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
• Females with hormone therapy will be excluded from the study
• Lean healthy subjects representing one or more of the following criteria are excluded from participation in the study.
• Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• University Hospital, Geneva: collaborator
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• Imperial College London: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain Golay, Prof

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 29, 2016
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: April 1, 2011
• Last Updated: February 29, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share