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NCT Number: NCT03076424

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Neuropsychiatric Research Institute (NRI)

Fargo, North Dakota, 58103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

No intervention used

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

North Dakota State University

Other

Collaborators

  • Neuropsychiatric Research Institute, Fargo, North Dakota

Registry information

Official study title

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

Acronym: NI-MWG

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2017
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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