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

Completed

• Conditions: Obesity; Type2 Diabetes
• Interventions: Other: no intervention used

• Registration Number: NCT03076424
• Lead Sponsor: North Dakota State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-03-06
• Study Start: 2017-03-08
• Study First Posted: 2017-03-10
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	no intervention used	Obese patients (BMI greater than or equal to 30 kg/m2) with Type 2 Diabetes Mellitus.
2	no intervention used	Obese patients (BMI greater than or equal to 30 kg/m2) without Type 2 Diabetes Mellitus.
3	no intervention used	Normal weight lean controls without Type 2 Diabetes Mellitus.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Neuropsychiatric Research Institute (NRI); 🇺🇸 Fargo, North Dakota, United States