Human Faecal Microbiota in Type 2 Diabetes
26. Februar 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
67
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
30 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Lean non diabetic
Lean and healthy subjects receiving no intervention
|
|
|
Experimental: Overweight non diabetic
fiber rich cereal bars, two bars a day for 4 weeks
|
Two cereals per day and per subject for 4 weeks
Andere Namen:
|
|
Experimental: Overweight diabetic
fiber rich cereal bars, two bars a day for 4 weeks
|
Two cereals per day and per subject for 4 weeks
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fecal microbiota profile
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Metabonomic analysis in faeces
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Alain Golay, Prof, University Hospital, Geneva
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2007
Primärer Abschluss (Tatsächlich)
1. Juni 2009
Studienabschluss (Tatsächlich)
1. April 2011
Studienanmeldedaten
Zuerst eingereicht
18. Februar 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Februar 2016
Zuerst gepostet (Schätzen)
29. Februar 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
29. Februar 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Februar 2016
Zuletzt verifiziert
1. Februar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 06.42.NRC
Plan für individuelle Teilnehmerdaten (IPD)
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