Role of bacterioPhages In gut Microbiome composition and glucose metabolism in Metabolic Syndrome subjects

Recruiting

Conditions: Metabolic Syndrome
insulin resistance

Registration Number: NL-OMON26916

Lead Sponsor: Investigator initiated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

•Caucasian male/female
•Age: =18 years old
•BMI: =25 kg/m2
•At least 3 of the following criteria:
oFasting plasma glucose =5.6 mmol/L OR HOMA-IR index =2.5 (HOMA-IR is measured as (fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135)
oWaist-circumference =102 cm
oHDL-cholesterol =1.02 mmol/L
oBlood pressure =130/85 mmHg
oTriglycerides =1.7 mmol/L
•Subjects should be able to give informed consent

Exclusion Criteria

•A history of cardiovascular event (cerebrovascular accident (CVA), myocardial infarction (MI)) or pacemaker implantation
•Use of any medication including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period
•(Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4 count < 240/mm3)
•Presence of overt type 1 diabetes mellitus (T1DM) or T2D
•History of chronic diarrhoea (=3 stools/day for >4 weeks), chronic obstipation (<2 defecations/week for >3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
•Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period
•Use of >5 units of alcohol daily on average in the past three months or use of >2 units of alcohol during the study period
•History of cholecystectomy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the effect of lean-donor phage transplantation with placebo treatment (saline) on glucose tolerance (via an OGTT) in obese, insulin resistant subjects at risk to develop diabetes.

Secondary Outcome Measures

Name	Time	Method
To assess and compare changes in gut microbiota and phage composition following phage transplantation and placebo:<br>•An overview of the dynamic changes in gut microbiota and virome population following phage transplantation compared to placebo.<br>•A comparison between phage composition in individuals at risk to develop T2DM at baseline with phage composition in lean, healthy subjects (donors).