Clinical trial NCT03076424: The Effect of Nutrient Intake on the Microbiome, Weight, and Glucoregulation (NI-MWG)
Official title: Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type2 Diabetes
Lead sponsor: North Dakota State University
Sponsor class: OTHER
Collaborators: name: Neuropsychiatric Research Institute, Fargo, North Dakota
First posted: 2017-03-10
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese diabetics, obese non-diabetics and controls

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Intestinal Microbiome Composition
timeFrame: One sample collected upon study enrollment
Secondary outcomes:
measure: Fasting Glucose
timeFrame: One sample collected upon study enrollment
measure: Fasting Insulin
timeFrame: One sample collected upon study enrollment
measure: C-peptide
timeFrame: One sample collected upon study enrollment
measure: Hemoglobin A1-c
timeFrame: One sample collected upon study enrollment
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute (NRI)
state: North Dakota
Study officials:
References: