Insulin SensitivityPhase 2MicroB2NCT02127125

Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)

A Phase 2 study testing Maltodextrin, Synbiotic and Sevelamer in people with Insulin Sensitivity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether microbiome modulation and an experimental reduction in plasma LPS concentration improve inflammation and insulin action in insulin resistant (obese and T2DM) subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Insulin Sensitivity
What is being tested?: Maltodextrin, Synbiotic and Sevelamer
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2014to 10 Sep 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Both genders (50%, male). All races and ethnic groups.
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for ≥6 months.
Hematocrit (HCT)≥ 34%, serum creatinine ≤ 1.4 mg/dl, and normal results of serum electrolytes, urinalysis, and coagulation tests. Liver function tests (LFTs) up to 2 times normal
Stable body weight (±2%) for ≥ 3 months.
Two or less sessions of strenuous exercise/wk for last 6 months.

Who cannot join

Current treatment with drugs known to affect glucose and lipid homeostasis. If the subject has been on a stable dose for the past 3 months, the following agents will be permitted: calcium channel blockers, β-blockers, ACE inhibitors, angiotensin receptor blockers, and statins
History of allergy to sevelamer.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than a week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsy in accordance with the primary physician.
Use of agents that affect gut flora (e.g. antibiotics, colestyramine, lactulose, PEG) within 3 months.
History of heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.

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Poorly controlled blood pressure (systolic BP>170, diastolic BP>95 mmHg).
Active inflammatory, autoimmune, hepatic, gastrointestinal, malignant, and psychiatric disease.
History of gastrointestinal surgery or gastrointestinal obstruction within two years.

Trial locations and contacts

1 site in 1 country.

United States1 site

Audie L. Murphy VA Hospital, STVHCS
San Antonio, Texas, 78229

Other trials in United States

About this study

Read the detailed description

In this Aim we will test the hypothesis that lowering lipopolysaccharide (LPS) concentration in the circulation will improve systemic (muscle) inflammation and glucose metabolism in insulin resistant (obese and T2DM) subjects by protecting the intestinal barrier with a synbiotic (Bifidobacterium longum R0175 and oligofructose) or by sequestering LPS in the gastrointestinal lumen with sevelamer.

Conditions: Insulin Sensitivity
Being tested: Maltodextrin, Synbiotic, Sevelamer
Medical subject headings: Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MaltodextrinDrug
Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
SynbioticDrug
Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
SevelamerDrug
Also called Renvela
Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks

Study groups in NCT02127125
Study group	Role	What they receive
Type2 Diabetes Mellitus - Placebo	Placebo comparator	Type 2 Diabetes Mellitus subjects will receive maltodextrin (placebo) Receives: Drug: Maltodextrin
Obese with NGT - Placebo	Placebo comparator	Obese (BMI = 30-37 kg/m2) normal glucose tolerant (NGT) subjects will receive maltodextrin (placebo) Receives: Drug: Maltodextrin
Lean with NGT -Placebo	Placebo comparator	Lean (BMI< 26 kg/m2) normal glucose tolerant (NGT) will receive maltodextrin (placebo) Receives: Drug: Maltodextrin
Type2 Diabetes Mellitus - Synbiotic	Active comparator	Type 2 Diabetic subjects will receive synbiotic Receives: Drug: Synbiotic
Type2 Diabetes Mellitus - Sevelamer	Active comparator	Type 2 Diabetic subjects will receive sevelamer Receives: Drug: Sevelamer
Obese with NGT - Synbiotic	Active comparator	Obese (BMI = 30-37 kg/m2) normal glucose tolerant subjects (NGT) will receive Synbiotic Receives: Drug: Synbiotic
Obese with NGT - Sevelamer	Active comparator	Obese subjects (BMI = 30-37 kg/m2) normal glucose tolerant (NGT) will receive Sevelamer Receives: Drug: Sevelamer
Lean with NGT - Synbiotic	Active comparator	Lean (BMI< 26 kg/m2) normal glucose tolerant (NGT) will receive Synbiotic Receives: Drug: Synbiotic
Lean with NGT - Sevelamer	Active comparator	Lean (BMI< 26 kg/m2) normal glucose tolerant (NGT) will receive Sevelamer Receives: Drug: Sevelamer

What is being measured

The primary outcome is the main question the study is designed to answer.

Insulin Sensitivity
Insulin sensitivity in skeletal muscle (M value) as measured by hyperinsulinemic euglycemic clamp study. The clamp study tests the ability of peripheral tissues such as skeletal muscle to uptake glucose in response to a constant insulin stimulus, which give a measure of sensitivity to insulin action. 60 mU/m2*min insulin was infused into subjects for 180 minutes with concomitant adjustment of glucose infusion rate using D20 glucose to maintain a clamped plasma glucose concentration of 100 mg/dL. When the glucose infusion rate equals the rate of glucose uptake and the targeted glucose concentration is achieved, the clamp is at steady-state equilibrium. Steady-state glucose infusion rate at 150min-180mins was used as the measure to calculate the M value.
Measured: Change from baseline insulin sensitivity at 28 days of the intervention.

Secondary outcomes (2)

Plasma Endotoxin Level and Its Panel.
Plasma Lipopolysaccharide (LPS) after intervention period
Measured: Change from baseline plasma endotoxin level and its panel during 28 days.
Gut Permeability
urine lactulose: mannitol ratio.
Measured: Change from baseline gut permeability at 24 days of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201410 Sep 2018

First posted30 Apr 2014 (estimated)
Study start10 Apr 2014
Primary completionSep 2018
Study completion10 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Insulin SensitivityStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center at San AntonioThe 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02127125
Sponsor's protocol ID: HSC20130458H
Acronym: MicroB2
Status last verified: Aug 2020
First submitted: 24 Apr 2014
Last updated: 11 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Baeuerle E, Semwal MK, Nie J, Zhang N, Liang H, Ganapathy V, Sathavarodom N, Fernandez R, Wang CP, Espinoza S, Dong Q, Gao X, Yang Z, Kostic A, Musi N. Effect of Sevelamer and B. longum on Insulin Sensitivity in Participants With Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2026 Jul;34(7):1382-1394. doi: 10.1002/oby.70224. Epub 2026 May 15.
PubMed 42141362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
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Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
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All Insulin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)
ClinicalTrials.gov ID: NCT02127125
Acronym / sponsor ID: MicroB2 / HSC20130458H
Conditions: Insulin Sensitivity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Collaborators: American Diabetes Association
Study start: 10 Apr 2014 (actual)
Primary completion: Sep 2018 (actual)
Study completion: 10 Sep 2018 (actual)
First posted: 30 Apr 2014 (estimated)
Results: Posted 11 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 9

Arm	Type	Receives
Type2 Diabetes Mellitus - Placebo	Placebo comparator	Drug: MaltodextrinType 2 Diabetes Mellitus subjects will receive maltodextrin (placebo)
Obese with NGT - Placebo	Placebo comparator	Drug: MaltodextrinObese (BMI = 30-37 kg/m2) normal glucose tolerant (NGT) subjects will receive maltodextrin (placebo)
Lean with NGT -Placebo	Placebo comparator	Drug: MaltodextrinLean (BMI< 26 kg/m2) normal glucose tolerant (NGT) will receive maltodextrin (placebo)
Type2 Diabetes Mellitus - Synbiotic	Active comparator	Drug: SynbioticType 2 Diabetic subjects will receive synbiotic
Type2 Diabetes Mellitus - Sevelamer	Active comparator	Drug: SevelamerType 2 Diabetic subjects will receive sevelamer
Obese with NGT - Synbiotic	Active comparator	Drug: SynbioticObese (BMI = 30-37 kg/m2) normal glucose tolerant subjects (NGT) will receive Synbiotic
Obese with NGT - Sevelamer	Active comparator	Drug: SevelamerObese subjects (BMI = 30-37 kg/m2) normal glucose tolerant (NGT) will receive Sevelamer
Lean with NGT - Synbiotic	Active comparator	Drug: SynbioticLean (BMI< 26 kg/m2) normal glucose tolerant (NGT) will receive Synbiotic
Lean with NGT - Sevelamer	Active comparator	Drug: SevelamerLean (BMI< 26 kg/m2) normal glucose tolerant (NGT) will receive Sevelamer

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Both genders (50%, male). All races and ethnic groups.
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for ≥6 months.
Hematocrit (HCT)≥ 34%, serum creatinine ≤ 1.4 mg/dl, and normal results of serum electrolytes, urinalysis, and coagulation tests. Liver function tests (LFTs) up to 2 times normal
Stable body weight (±2%) for ≥ 3 months.
Two or less sessions of strenuous exercise/wk for last 6 months.

Key exclusion criteria (9 listed)

Current treatment with drugs known to affect glucose and lipid homeostasis. If the subject has been on a stable dose for the past 3 months, the following agents will be permitted: calcium channel blockers, β-blockers, ACE inhibitors, angiotensin receptor blockers, and statins
History of allergy to sevelamer.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than a week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsy in accordance with the primary physician.
Use of agents that affect gut flora (e.g. antibiotics, colestyramine, lactulose, PEG) within 3 months.

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
MaltodextrinMaltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.	Drug	Lean with NGT -Placebo, Obese with NGT - Placebo, Type2 Diabetes Mellitus - Placebo
SynbioticSynbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.	Drug	Lean with NGT - Synbiotic, Obese with NGT - Synbiotic, Type2 Diabetes Mellitus - Synbiotic
SevelamerAlso: RenvelaSevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks	Drug	Lean with NGT - Sevelamer, Obese with NGT - Sevelamer, Type2 Diabetes Mellitus - Sevelamer

Primary outcome

Insulin Sensitivity
Time frame: Change from baseline insulin sensitivity at 28 days of the intervention.
Insulin sensitivity in skeletal muscle (M value) as measured by hyperinsulinemic euglycemic clamp study. The clamp study tests the ability of peripheral tissues such as skeletal muscle to uptake glucose in response to a constant insulin stimulus, which give a measure of sensitivity to insulin action. 60 mU/m2*min insulin was infused into subjects for 180 minutes with concomitant adjustment of glucose infusion rate using D20 glucose to maintain a clamped plasma glucose concentration of 100 mg/dL. When the glucose infusion rate equals the rate of glucose uptake and the targeted glucose concentration is achieved, the clamp is at steady-state equilibrium. Steady-state glucose infusion rate at 150min-180mins was used as the measure to calculate the M value.

2 secondary outcomes

Plasma Endotoxin Level and Its Panel.
Time frame: Change from baseline plasma endotoxin level and its panel during 28 days.
Gut Permeability
Time frame: Change from baseline gut permeability at 24 days of the intervention.

Results and safety

Results posted to the registry on 11 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lean With NGT-Placebo	6	6
Lean With NGT-Sevelamer	8	8
Lean With NGT-Synbiotic	9	8
Obese With NGT-Placebo	11	10
Obese With NGT-Sevelamer	12	9
Obese With NGT-Synbiotic	12	9
Type 2 Diabetes -Placebo	2	2
Type 2 Diabetes-Sevelamer	0	0
Type 2 Diabetes-Synbiotic	1	1

Primary outcome: Insulin Sensitivity

Time frame: Change from baseline insulin sensitivity at 28 days of the intervention.. Mean (Standard Deviation). Unit: M Value (mg/kg/min)

Measure	Lean With NGT-Placebo n = 6	Lean With NGT-Sevelamer n = 8	Lean With NGT-Synbiotic n = 8	Obese With NGT-Placebo n = 10	Obese With NGT-Sevelamer n = 9	Obese With NGT-Synbiotic n = 9	Type 2 Diabetes-Placebo n = 2	Type 2 Diabetes-Sevelamer n = 0	Type 2 Diabetes-Synbiotic n = 1
Value	10.16 (3.78)	8.45 (2.25)	9.47 (2.59)	5.96 (2.24)	8.14 (2.138)	5.45 (1.88)	3.81 (.386)	–	1.42

Obese With NGT-Placebo vs Obese With NGT-Sevelamer: p <0.025, Generalized Estimating Equation
Obese With NGT-Placebo vs Obese With NGT-Synbiotic: p >0.05, Generalized Estimating Equation

Population analysed: Enrollment and completion for Type 2 diabetes mellitus group was low due to exclusionary criteria that prevented most diabetes medications from being used while in the study. Lean with NGT and Obese with NGT groups completed 6 control, 8 sevelamer, 8 synbiotic subjects for Lean group and 10 control, 9 sevelamer and 9 synbiotic for Obese group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study participants were enrolled in the study for approximately 2-3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lean With NGT-Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Lean With NGT-Sevelamer	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Lean With NGT-Synbiotic	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Obese With NGT-Placebo	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Obese With NGT-Sevelamer	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Obese With NGT-Synbiotic	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
Type 2 Diabetes-Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Type 2 Diabetes-Sevelamer	0 of 0	0 of 0	0
Type 2 Diabetes-Synbiotic	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42141362Baeuerle E, Semwal MK, Nie J, Zhang N, Liang H, Ganapathy V, Sathavarodom N, Fernandez R, Wang CP, Espinoza S, Dong Q, Gao X, Yang Z, Kostic A, Musi N. Effect of Sevelamer and B. longum on Insulin Sensitivity in Participants With Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2026 Jul;34(7):1382-1394. doi: 10.1002/oby.70224. Epub 2026 May 15.

Related trials for Insulin Sensitivity

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes

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.

Nicolas Musi, MD. principal investigator

The University of Texas Health Science Center at San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Maltodextrin, Synbiotic and Sevelamer in people with Insulin Sensitivity, run by The University of Texas Health Science Center at San Antonio 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 9 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 11 Sep 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Insulin Sensitivity (time frame: Change from baseline insulin sensitivity at 28 days of the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02127125, which also lists 1 linked publication.

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 11 Sep 2020.