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Human Faecal Microbiota in Type 2 Diabetes

26. února 2016 aktualizováno: Société des Produits Nestlé (SPN)

Analysis of the Diversity of Faecal Bacteria in Healthy and Type 2 Diabetic Subjects

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The diversity and quantity of bacteria vary depending on age of the individuals, daily diet and the segment of the intestine, which makes the gut microbiota one of the most complex bacterial ecosystems known to men. In general, over trillions of bacteria reside in human gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat storage or obesity has become one of the leading public health issues in many developed and developing countries. However, it is not clear whether type 2 diabetes is associated with a unique gut microbiota profile. Therefore, the primary objective of the study is to compare the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI matched subjects as well as with lean non-diabetic subjects. In addition, the investigators hypothesize that microbiota modifications with consumption of fiber rich food products can improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the investigators plan to provide each overweight participant with two cereal bars per day for 4 weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will be determined.

Typ studie

Intervenční

Zápis (Aktuální)

67

Fáze

  • Nelze použít

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

30 let až 55 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

-All diabetic and control non-diabetic subjects (of same BMI) must comply with all the following inclusion criteria:

  • 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

Lean non-diabetic healthy subjects must comply with the following inclusion criteria:

  • 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

Exclusion Criteria:

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
  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Lean non diabetic
Lean and healthy subjects receiving no intervention
Experimentální: Overweight non diabetic
fiber rich cereal bars, two bars a day for 4 weeks
Jiný: Fiber rich cereal bars
Two cereals per day and per subject for 4 weeks
Ostatní jména:
  • Nutren balance bars
Experimentální: Overweight diabetic
fiber rich cereal bars, two bars a day for 4 weeks
Jiný: Fiber rich cereal bars
Two cereals per day and per subject for 4 weeks
Ostatní jména:
  • Nutren balance bars

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fecal microbiota profile
Časové okno: Baseline samples taken after 2 weeks of diet normalization period
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Metabonomic analysis in faeces
Časové okno: Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
Samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in plasma
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in urine
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma glucose
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma insulin
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma free fatty acids
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma triglycerides
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma total cholesterol
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma HDL cholesterol
Časové okno: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Société des Produits Nestlé (SPN)

Spolupracovníci

University Hospital, Geneva
Imperial College London
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alain Golay, Prof, University Hospital, Geneva

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2007

Primární dokončení (Aktuální)

1. června 2009

Dokončení studie (Aktuální)

1. dubna 2011

Termíny zápisu do studia

První předloženo

18. února 2016

První předloženo, které splnilo kritéria kontroly kvality

26. února 2016

První zveřejněno (Odhad)

29. února 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

29. února 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. února 2016

Naposledy ověřeno

1. února 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 06.42.NRC

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