Obesity, Type2 Diabetes
Conditions
Brief summary
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.
Interventions
OTHERno intervention used
Patients will be giving a blood sample after 8 hours of fasting.
Sponsors
Neuropsychiatric Research Institute, Fargo, North Dakota
North Dakota State University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female 2. Age 18-65 (inclusive, at time of informed consent) 3. BMI ≥ 30 kg/m2 with T2DM 4. BMI ≥ 30 kg/m2 without T2DM 5. Normal weight lean controls without T2DM
Exclusion criteria
1. Tobacco use in past three months - will add unnecessary confound to the data. 2. 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) 3. Has taken an oral or injectable antibiotic in the past 3 months 4. Has taken a commercially prepared probiotic and/or prebiotic agent in the 3 months 5. History of significant intestinal disease or disorder (e.g., crohn's disease, ulcerative colitis) 6. History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator 7. Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator. 8. Unable to speak/read English 9. Breastfeeding, pregnant, or planning to become pregnant within the duration of the study as assessed through self-report on medical history 10. 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. 11. Any known infectious disease such as Viral Hepatitis or HIV (as determined by study pharmacist/MD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal Microbiome Composition | One sample collected upon study enrollment | The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose | One sample collected upon study enrollment | Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups. |
| Fasting Insulin | One sample collected upon study enrollment | Plasma insulin (fasting) will be measured from collected blood sample and compared between the 3 subject groups. |
| C-peptide | One sample collected upon study enrollment | c-peptide will be measured from collected blood sample and compared between the 3 subject groups. |
| Hemoglobin A1-c | One sample collected upon study enrollment | hemoglobin A1-c will be measured from collected blood sample and compared between the 3 subject groups. |
Countries
United States
Outcome results
None listed