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

Study Overview
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Brief Summary
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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.

Official Title
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Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?

Conditions
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Obesity, Type2 Diabetes

Intervention / Treatment
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* Other: no intervention used


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Obese patients (BMI greater than or equal to 30 kg/m2) with Type 2 Diabetes Mellitus. | Other: no intervention used<br>* Patients will be giving a blood sample after 8 hours of fasting.<br>|
| 2<br>Obese patients (BMI greater than or equal to 30 kg/m2) without Type 2 Diabetes Mellitus. | Other: no intervention used<br>* Patients will be giving a blood sample after 8 hours of fasting.<br>|
| 3<br>Normal weight lean controls without Type 2 Diabetes Mellitus. | Other: no intervention used<br>* Patients will be giving a blood sample after 8 hours of fasting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Microbiome Composition | The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation. | One sample collected upon study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose | Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment | 
| Fasting Insulin | Plasma insulin (fasting) will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment | 
| C-peptide | c-peptide will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment | 
| Hemoglobin A1-c | hemoglobin A1-c will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment |