Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076424
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
Kristine Steffen, 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.

Condition or disease Intervention/treatment
Obesity Type2 Diabetes Other: no intervention used

Layout table for study information
Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.




Primary Outcome Measures :
  1. Intestinal Microbiome Composition [ Time Frame: One sample collected upon study enrollment ]
    The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.


Secondary Outcome Measures :
  1. Fasting Glucose [ Time Frame: One sample collected upon study enrollment ]
    Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups.

  2. Fasting Insulin [ Time Frame: One sample collected upon study enrollment ]
    Plasma insulin (fasting) will be measured from collected blood sample and compared between the 3 subject groups.

  3. C-peptide [ Time Frame: One sample collected upon study enrollment ]
    c-peptide will be measured from collected blood sample and compared between the 3 subject groups.

  4. Hemoglobin A1-c [ Time Frame: One sample collected upon study enrollment ]
    hemoglobin A1-c will be measured from collected blood sample and compared between the 3 subject groups.


Biospecimen Retention:   Samples Without DNA
plasma/serum samples and fecal samples will be collected from each patient.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obese diabetics, obese non-diabetics and controls
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076424


Locations
Layout table for location information
United States, North Dakota
Neuropsychiatric Research Institute (NRI)
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
North Dakota State University
Neuropsychiatric Research Institute, Fargo, North Dakota

Layout table for additonal information
Responsible Party: Kristine Steffen, Associate Professor, Pharm. D., Ph.D., North Dakota State University
ClinicalTrials.gov Identifier: NCT03076424     History of Changes
Other Study ID Numbers: NDSU-PS
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018