Neuropsychiatric Research Institute (NRI)
Fargo, North Dakota, 58103, United States
NCT Number: NCT03076424
The purpose of this study is to investigate a persons dietary intake and its effect on the gut microbiome and the association of those two variables on weight and glucoregulation. Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin, c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2) with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to investigate the association with diet, microbiome and weight/glucoregulation.
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Notify Me18 year–65 year
Female
Observational
Fargo, North Dakota, 58103, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be giving a blood sample after 8 hours of fasting.
Time frame: One sample collected upon study enrollment
The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
Time frame: One sample collected upon study enrollment
Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups.
Time frame: One sample collected upon study enrollment
Plasma insulin (fasting) will be measured from collected blood sample and compared between the 3 subject groups.
Time frame: One sample collected upon study enrollment
c-peptide will be measured from collected blood sample and compared between the 3 subject groups.
Time frame: One sample collected upon study enrollment
hemoglobin A1-c will be measured from collected blood sample and compared between the 3 subject groups.
North Dakota State University
Other
Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?
Acronym: NI-MWG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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