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

NCT03076424 | Completed

• 1 other identifier: NDSU-PS
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fasting Glucose

  One sample collected upon study enrollment

• Fasting Insulin

  One sample collected upon study enrollment

• C-peptide

  One sample collected upon study enrollment

• Hemoglobin A1-c

  One sample collected upon study enrollment

Study Arms (3)

1

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

Other: no intervention used

2

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

Other: no intervention used

3

Normal weight lean controls without Type 2 Diabetes Mellitus.

Other: no intervention used

Interventions

no intervention used OTHER

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese diabetics, obese non-diabetics and controls

You may qualify if:

• Female
• Age 18-65 (inclusive, at time of informed consent)
• BMI ≥ 30 kg/m2 with T2DM
• BMI ≥ 30 kg/m2 without T2DM
• Normal weight lean controls without T2DM

You may not qualify if:

• Tobacco use in past three months - will add unnecessary confound to the data.
• 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)
• Has taken an oral or injectable antibiotic in the past 3 months
• Has taken a commercially prepared probiotic and/or prebiotic agent in the 3 months
• History of significant intestinal disease or disorder (e.g., crohn's disease, ulcerative colitis)
• History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator
• Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
• Unable to speak/read English
• Breastfeeding, pregnant, or planning to become pregnant within the duration of the study as assessed through self-report on medical history
• 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.
• Any known infectious disease such as Viral Hepatitis or HIV (as determined by study pharmacist/MD)

Sponsors & Collaborators

• North Dakota State University: lead
• Neuropsychiatric Research Institute, Fargo, North Dakota: collaborator

Study Sites (1)

Neuropsychiatric Research Institute (NRI)

Fargo, North Dakota, 58103, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma/serum samples and fecal samples will be collected from each patient.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pharm. D., Ph.D.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 10, 2017
• Study Start: March 8, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

US (1)