The Effect of Nutrient Intake on the Microbiome, Weight, and Glucoregulation (NI-MWG)

Completed

Conditions studied: Obesity, Type2 Diabetes

In brief

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.

Key facts

Study ID

NCT03076424

Run by

North Dakota State University

People needed

19

Starts

2017-03-08

Expected to finish

2017-12-31

Last updated by the study team

2018-08-23

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female
• Age 18-65 (inclusive, at time of informed consent)
• BMI ≥ 30 kg/m2 with T2DM
• BMI ≥ 30 kg/m2 without T2DM
• Normal weight lean controls without T2DM

You may not qualify if…

• Tobacco use in past three months - will add unnecessary confound to the data.
• Taking a medication on a routine/recent basis which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD)
• Has taken an oral or injectable antibiotic in the past 3 months
• Has taken a commercially prepared probiotic and/or prebiotic agent in the 3 months
• History of significant intestinal disease or disorder (e.g., crohn's disease, ulcerative colitis)
• History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator
• Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
• Unable to speak/read English
• Breastfeeding, pregnant, or planning to become pregnant within the duration of the study as assessed through self-report on medical history
• Unwilling to use a medically acceptable form of contraception during study involvement. Medically acceptable forms of contraception include oral contraception, physical barrier methods and/or abstinence.
• Any known infectious disease such as Viral Hepatitis or HIV (as determined by study pharmacist/MD)

Where it is running

• Neuropsychiatric Research Institute (NRI) — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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