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

NCT ID: NCT03076424

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2017-12-31

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.

Conditions

Obesity; Type2 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Obese patients (BMI greater than or equal to 30 kg/m2) with Type 2 Diabetes Mellitus.

no intervention used

Intervention Type: OTHER

Patients will be giving a blood sample after 8 hours of fasting.

2

Obese patients (BMI greater than or equal to 30 kg/m2) without Type 2 Diabetes Mellitus.

no intervention used

Intervention Type: OTHER

Patients will be giving a blood sample after 8 hours of fasting.

3

Normal weight lean controls without Type 2 Diabetes Mellitus.

no intervention used

Intervention Type: OTHER

Patients will be giving a blood sample after 8 hours of fasting.

Interventions

no intervention used

Patients will be giving a blood sample after 8 hours of fasting.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Neuropsychiatric Research Institute, Fargo, North Dakota

OTHER

Sponsor Role: collaborator

North Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Kristine Steffen

Associate Professor, Pharm. D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neuropsychiatric Research Institute (NRI)

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

NDSU-PS

Identifier Type: -

Identifier Source: org_study_id