ObesityMISSNCT03120871
Microbiome Insulin Sensitivity Study
An observational study of Obesity and Insulin Resistance, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The Microbiome Insulin Sensitivity Study "MISS" is a pilot study designed to study microbiome composition across puberty and how it relates to insulin sensitivity and secretion in obese girls, who are at increased risk for developing type 2 diabetes in puberty. Read more about this study
- Who is it for?
- Ages 9 to 17 years, women only
- Conditions the study is for
- Obesity, Insulin Resistance, Type2 Diabetes
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to 19 Aug 2018
- 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 9 to 17 years
- Women only
- Child
Study population: 19 prepubertal (Tanner 1, [T1]), 19 early pubertal (T2-3), 19 late pubertal (T4-5) obese (BMI>95%ile) females, age >9 years.
Who may be able to join
- Female sex
- Obesity (BMI > 95th percentile for age)
- Age > 9 years, <18 years
Who cannot join
- Medications affecting glucose metabolism
- Known T2D
- Known polycystic ovarian syndrome
- Known fatty liver disease (ALT > 2x above the upper limit of normal)
- Chronic illness affecting glucose metabolism
- Antibiotic use in the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Sex Differences in Youth-Onset Type 2 Diabetes: Exploring Mechanisms
The Microbiome Insulin Sensitivity Study "MISS" is a pilot study designed to study microbiome composition across puberty and how it relates to insulin sensitivity and secretion in obese girls, who are at increased risk for developing type 2 diabetes in puberty. The investigators will evaluate the gut microbiome composition in fecal samples of 57 obese girls in three groups: prepubertal (Tanner 1), early pubertal (Tanner 2-3), and late pubertal (Tanner 4-5). Insulin sensitivity will also be measured via an intravenous glucose tolerance test (IVGTT) in 18 prepubertal and late pubertal participants.
Read the detailed description
Pediatric type 2 diabetes (T2D) is increasing in prevalence and its incidence is twice as high in girls as in boys. Pediatric onset of T2D occurs exclusively in obese youth and is tightly linked with puberty, suggesting a link with the physiologic insulin resistance of puberty. However, markers are as yet unavailable to identify those at highest risk for progression to T2D. Results from the Treatment Options for Diabetes in Youth (TODAY) Study demonstrate that pediatric T2D appears to progress rapidly in youth, forecasting poor quality of life and early complications. Therefore, identifying those most at risk and developing a better understanding of the pathophysiology of onset of T2D in youth are critical for preventing T2D, particularly in obese girls.
The investigators overarching hypothesis is that effects of obesity on metabolic and hormonal changes during puberty place obese girls at greatest risk for early T2D, similar to that which is seen in women with gestational diabetes. More specifically, sex steroid effects on insulin resistance, β-cell function, and body composition may contribute to both the pubertal increase in risk for T2D, as well as the disproportionately higher prevalence of T2D among girls. The investigators long-term goal is to design a focused intervention aimed to prevent progression to T2D during puberty. In order to do this it is necessary to: 1. Develop a better understanding of underlying mechanisms for β-cell failure in obese youth during puberty, and 2. Identify early markers for predicting which obese youth will progress to early T2D.
Alterations in gut microbiota appear to play an important role in mediating obesity and insulin resistance through poorly understood mechanisms. Current hypotheses are that shifts in the composition of the gut microbiome lead to dysregulation of complex polysaccharide metabolism, altered production of gut hormones regulating energy balance, and local and systemic inflammation. The gut microbiome composition has been reported to change during pregnancy and may play a role in metabolic changes during this time. As metabolic and hormonal changes in puberty parallel those in pregnancy, shifts in the microbiome may also accompany metabolic shifts during puberty. Currently, there are no published studies evaluating shifts in human gut microbiome composition during puberty. Consequently, the overall goal of this study is to collect cross-sectional preliminary data to inform feasibility of a future longitudinal study of metabolic and hormonal changes in lean and obese youth during the pubertal transition.
- Conditions
- Obesity, Insulin Resistance, Type2 Diabetes
- Keywords
- Beta cell failure, Puberty, Microbiome, Insulin Sensitivity
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Female sex, obese, aged 9-17 years, Tanner stages 1-5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firmicutes:Bacteroides ratio (F:B Ratio)
F:B ratio in prepubertal, early pubertal, and late pubertal obese girls by high-throughput 16S ribosomal ribonucleic acid (16 S rRNA) sequencing from stool samples.
Measured: Within 2 weeks of enrollment
Insulin sensitivity (Si)
Insulin sensitivity (Si) estimated from IV glucose tolerance testing using Bergman's minimal model
Measured: Within 2 weeks of enrollment
Secondary outcomes (3)
Urinary estradiol metabolites (E1c)
Measurement of estrogen metabolites in first morning urine sample and normalized to creatinine
Measured: Within 2 weeks of enrollment
Urinary luteinizing hormone (LH)
Measurement of LH in first morning urine sample and normalized to creatinine
Measured: Within 2 weeks of enrollment
Urinary follicle stimulating hormone (FSH)
Measurement of FSH in first morning urine sample and normalized to creatinine
Measured: Within 2 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start12 May 2017
- Primary completion19 Aug 2018
- Study completion19 Aug 2018
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Megan M Kelsey, MD, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120871
- Sponsor's protocol ID
- 16-2633
- Other IDs
- UL1TR001082
- Acronym
- MISS
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2017
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Youth-Onset Type 2 Diabetes: Exploring Mechanisms
- ClinicalTrials.gov ID
- NCT03120871
- Acronym / sponsor ID
- MISS / 16-2633
- Conditions
- Obesity, Insulin Resistance, Type2 Diabetes
- Keywords
- Beta cell failure, Puberty, Microbiome, Insulin Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Children's Hospital Colorado
- Study start
- 12 May 2017 (actual)
- Primary completion
- 19 Aug 2018 (actual)
- Study completion
- 19 Aug 2018 (actual)
- First posted
- 19 Apr 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 Microbiome Insulin Sensitivity Study "MISS" is a pilot study designed to study microbiome composition across puberty and how it relates to insulin sensitivity and secretion in obese girls, who are at increased risk for developing type 2 diabetes in puberty. The investigators will evaluate the gut microbiome composition in fecal samples of 57 obese girls in three groups: prepubertal (Tanner 1), early pubertal (Tanner 2-3), and late pubertal (Tanner 4-5). Insulin sensitivity will also be measured via an intravenous glucose tolerance test (IVGTT) in 18 prepubertal and late pubertal participants.
Detailed description
Pediatric type 2 diabetes (T2D) is increasing in prevalence and its incidence is twice as high in girls as in boys. Pediatric onset of T2D occurs exclusively in obese youth and is tightly linked with puberty, suggesting a link with the physiologic insulin resistance of puberty. However, markers are as yet unavailable to identify those at highest risk for progression to T2D. Results from the Treatment Options for Diabetes in Youth (TODAY) Study demonstrate that pediatric T2D appears to progress rapidly in youth, forecasting poor quality of life and early complications. Therefore, identifying those most at risk and developing a better understanding of the pathophysiology of onset of T2D in youth are critical for preventing T2D, particularly in obese girls.
The investigators overarching hypothesis is that effects of obesity on metabolic and hormonal changes during puberty place obese girls at greatest risk for early T2D, similar to that which is seen in women with gestational diabetes. More specifically, sex steroid effects on insulin resistance, β-cell function, and body composition may contribute to both the pubertal increase in risk for T2D, as well as the disproportionately higher prevalence of T2D among girls. The investigators long-term goal is to design a focused intervention aimed to prevent progression to T2D during puberty. In order to do this it is necessary to: 1. Develop a better understanding of underlying mechanisms for β-cell failure in obese youth during puberty, and 2. Identify early markers for predicting which obese youth will progress to early T2D.
Alterations in gut microbiota appear to play an important role in mediating obesity and insulin resistance through poorly understood mechanisms. Current hypotheses are that shifts in the composition of the gut microbiome lead to dysregulation of complex polysaccharide metabolism, altered production of gut hormones regulating energy balance, and local and systemic inflammation. The gut microbiome composition has been reported to change during pregnancy and may play a role in metabolic changes during this time. As metabolic and hormonal changes in puberty parallel those in pregnancy, shifts in the microbiome may also accompany metabolic shifts during puberty. Currently, there are no published studies evaluating shifts in human gut microbiome composition during puberty. Consequently, the overall goal of this study is to collect cross-sectional preliminary data to inform feasibility of a future longitudinal study of metabolic and hormonal changes in lean and obese youth during the pubertal transition.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | –Female sex, obese, aged 9-17 years, Tanner stages 1-5. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- Female only
- Age groups
- Child
- Study population
- 19 prepubertal (Tanner 1, [T1]), 19 early pubertal (T2-3), 19 late pubertal (T4-5) obese (BMI>95%ile) females, age >9 years.
Key inclusion criteria (3 listed)
- Female sex
- Obesity (BMI > 95th percentile for age)
- Age > 9 years, <18 years
Key exclusion criteria (6 listed)
- Medications affecting glucose metabolism
- Known T2D
- Known polycystic ovarian syndrome
- Known fatty liver disease (ALT > 2x above the upper limit of normal)
- Chronic illness affecting glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Firmicutes:Bacteroides ratio (F:B Ratio)
Time frame: Within 2 weeks of enrollment
F:B ratio in prepubertal, early pubertal, and late pubertal obese girls by high-throughput 16S ribosomal ribonucleic acid (16 S rRNA) sequencing from stool samples.
Insulin sensitivity (Si)
Time frame: Within 2 weeks of enrollment
Insulin sensitivity (Si) estimated from IV glucose tolerance testing using Bergman's minimal model
3 secondary outcomes
Urinary estradiol metabolites (E1c)
Time frame: Within 2 weeks of enrollment
Urinary luteinizing hormone (LH)
Time frame: Within 2 weeks of enrollment
Urinary follicle stimulating hormone (FSH)
Time frame: Within 2 weeks of 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 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Megan M Kelsey, MD, MS principal investigator
University of Colorado, Denver
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 Insulin Resistance, run by University of Colorado, Denver 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 3 inclusion and 6 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 10 Oct 2023. 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?
Firmicutes:Bacteroides ratio (F:B Ratio) (time frame: Within 2 weeks of enrollment). The study lists 2 primary outcomes in all. 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 10 Oct 2023.