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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type2 Diabetes
• Intervention / Treatment: Other: no intervention used

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Neuropsychiatric Research Institute (NRI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Obese diabetics, obese non-diabetics and controls

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: North Dakota State University
• Collaborators: Neuropsychiatric Research Institute, Fargo, North Dakota

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NDSU-PS