ObesityNI-MWGNCT03076424
The Effect of Nutrient Intake on the Microbiome, Weight, and Glucoregulation (NI-MWG)
An observational study of Obesity and Type2 Diabetes, run by North Dakota State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type2 Diabetes
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese diabetics, obese non-diabetics and controls
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuropsychiatric Research Institute (NRI)
Fargo, North Dakota, 58103
About this study
Official title: 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.
- Conditions
- Obesity, Type2 Diabetes
- Being tested
- no intervention used
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention usedOther
Patients will be giving a blood sample after 8 hours of fasting.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Obese patients (BMI greater than or equal to 30 kg/m2) with Type 2 Diabetes Mellitus. Receives: Other: no intervention used | |
| 2 | Obese patients (BMI greater than or equal to 30 kg/m2) without Type 2 Diabetes Mellitus. Receives: Other: no intervention used | |
| 3 | Normal weight lean controls without Type 2 Diabetes Mellitus. Receives: Other: no intervention used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Microbiome Composition
The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
Measured: One sample collected upon study enrollment
Secondary outcomes (4)
Fasting Glucose
Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups.
Measured: 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.
Measured: One sample collected upon study enrollment
C-peptide
c-peptide will be measured from collected blood sample and compared between the 3 subject groups.
Measured: 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.
Measured: One sample collected upon study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start8 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Responsible party
- Principal investigator, Kristine Steffen, North Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076424
- Sponsor's protocol ID
- NDSU-PS
- Acronym
- NI-MWG
- Status last verified
- Aug 2018
- First submitted
- 22 Feb 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?
- ClinicalTrials.gov ID
- NCT03076424
- Acronym / sponsor ID
- NI-MWG / NDSU-PS
- Conditions
- Obesity, Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: no intervention usedObese patients (BMI greater than or equal to 30 kg/m2) with Type 2 Diabetes Mellitus. |
| 2 | – | Other: no intervention usedObese patients (BMI greater than or equal to 30 kg/m2) without Type 2 Diabetes Mellitus. |
| 3 | – | Other: no intervention usedNormal weight lean controls without Type 2 Diabetes Mellitus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese diabetics, obese non-diabetics and controls
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention usedPatients will be giving a blood sample after 8 hours of fasting. | Other | 1, 2, 3 |
Primary outcome
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.
4 secondary outcomes
Fasting Glucose
Time frame: One sample collected upon study enrollment
Fasting Insulin
Time frame: One sample collected upon study enrollment
C-peptide
Time frame: One sample collected upon study enrollment
Hemoglobin A1-c
Time frame: One sample collected upon study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type2 Diabetes, run by North Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Microbiome Composition (time frame: One sample collected upon study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.