Microbiome Characteristics and short-chain FATty acid metabolism in type 1 diabetes patients versus healthy controls

Microbiome Characteristics and short-chain FATty acid metabolism in type 1 diabetes patients versus healthy controls - MCFAT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38809

Enrollment

200

Registered

2013-07-09

Start date

2013-10-03

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Diabetes type 1 /

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients: 1. Definite diagnosis of type 1 diabetes i.e. positive auto-antibodies or unambiguous clinical picture 2. no concomitant medication (no statins, ACE/ATII inhibitors, PPI nor antibiotics) 3. Normal BMI: 18-25 kg/m2 4. A balanced, *western* diet (see appendix);healthy controls: 1. normal BMI 2. Caucasian 3. Balanced, 'western' diet

Exclusion criteria

Exclusion criteria: patients: 1. Ambiguous clinical picture i.e. features of type 2, or other types of diabetes 2. Complications of diabetes (retinopathy/neuropathy/microalbuminuria) 3. Medication use (eg statins, ACE/ATII inhibitors, PPI). 4. Antibiotic use in the last three months 5. (Regular) use of probiotics-containing food 6. A diet that is one-sided or unusual (see appendix) 7. Medical conditions that can be expected to affect glucose metabolism or gut microbiome 8. Chronic diarrhea;Healthy controls: 1. Medication use 2. Comorbid conditions 3. Antibiotic use in the last three months 4. (regular) use of probiotics-containing food 5. A one sided or unusual diet 6. Diarrhea

Design outcomes

Primary

Measure	Time frame
The primary study parameter will be short-chain fatty acids in feces and plasma (acetate, propionate, butyrate) in relation to glycemic control (HbA1c and daily insulin use) and plasma lipid profiles.	—

Secondary

Measure	Time frame
Secondary study parameters will be intestinal integrity and inflammatory tone (measured by fecal calprotectin), intestinal bacterial translocation (by plasma LPS-binding peptide) and plasma inflammatory markers (leukocytes, C-reactive protein). Gut microbiome differences which will be evaluated by HIT-chip and oral microbiome, obtained by oral mucosal swab and finally diet/caloric intake evaluated by 1 week diet lists.	—

Measure

Time frame

Secondary study parameters will be intestinal integrity and inflammatory tone (measured by fecal calprotectin), intestinal bacterial translocation (by plasma LPS-binding peptide) and plasma inflammatory markers (leukocytes, C-reactive protein). Gut microbiome differences which will be evaluated by HIT-chip and oral microbiome, obtained by oral mucosal swab and finally diet/caloric intake evaluated by 1 week diet lists.

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Countries

Netherlands

Outcome results