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Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2) (MicroB2)

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: NCT02127125
Recruitment Status : Completed
First Posted : April 30, 2014
Results First Posted : September 11, 2020
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Insulin Sensitivity
Interventions Drug: Maltodextrin
Drug: Synbiotic
Drug: Sevelamer
Enrollment 69
Recruitment Details  
Pre-assignment Details 69 participants were screened, 8 were screen failures, so not randomized.
Arm/Group Title Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes -Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Hide Arm/Group Description Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Period Title: Overall Study
Started [1] 6 8 9 11 12 12 2 0 1
Completed 6 8 8 10 9 9 2 0 1
Not Completed 0 0 1 1 3 3 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             0             0             2             1             0             0             0
Withdrawal by Subject             0             0             0             1             0             0             0             0             0
Physician Decision             0             0             1             0             1             2             0             0             0
[1]
Passed screening for inclusion in study, assigned to intervention after baseline measurements.
Arm/Group Title Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic Total
Hide Arm/Group Description Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 6 8 8 10 9 9 2 0 1 53
Hide Baseline Analysis Population Description
Low enrollment of Type 2 Diabetics in this study due to exclusionary medication criteria including many common diabetes medications such as metformin which interfere with microbiome content. Subjects were randomized to treatment and no diabetic subjects ended up in the sevelamer treatment group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 8 participants 10 participants 9 participants 9 participants 2 participants 0 participants 1 participants 53 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
7
  87.5%
8
 100.0%
10
 100.0%
8
  88.9%
9
 100.0%
2
 100.0%
0
1
 100.0%
51
  96.2%
>=65 years
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
0
   0.0%
2
   3.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 8 participants 10 participants 9 participants 9 participants 2 participants 0 participants 1 participants 53 participants
38.8  (14.3) 46.9  (15.7) 48.8  (12.7) 51.6  (9.5) 51.7  (12.4) 50.3  (8.4) 61.0  (1.4) 52.0  (0.0) 49.2  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 8 participants 10 participants 9 participants 9 participants 2 participants 0 participants 1 participants 53 participants
Female
4
  66.7%
5
  62.5%
6
  75.0%
8
  80.0%
6
  66.7%
6
  66.7%
1
  50.0%
0
1
 100.0%
37
  69.8%
Male
2
  33.3%
3
  37.5%
2
  25.0%
2
  20.0%
3
  33.3%
3
  33.3%
1
  50.0%
0
0
   0.0%
16
  30.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 8 participants 10 participants 9 participants 9 participants 2 participants 0 participants 1 participants 53 participants
Hispanic or Latino
2
  33.3%
4
  50.0%
4
  50.0%
6
  60.0%
6
  66.7%
6
  66.7%
0
   0.0%
0
1
 100.0%
29
  54.7%
Not Hispanic or Latino
4
  66.7%
4
  50.0%
4
  50.0%
4
  40.0%
3
  33.3%
3
  33.3%
2
 100.0%
0
0
   0.0%
24
  45.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 8 participants 8 participants 10 participants 9 participants 9 participants 2 participants 0 participants 1 participants 53 participants
6 8 8 10 9 9 2 1 53
1.Primary Outcome
Title Insulin Sensitivity
Hide Description 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.
Time Frame Change from baseline insulin sensitivity at 28 days of the intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Hide Arm/Group Description:
Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Overall Number of Participants Analyzed 6 8 8 10 9 9 2 0 1
Mean (Standard Deviation)
Unit of Measure: M Value (mg/kg/min)
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
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obese With NGT-Placebo, Obese With NGT-Sevelamer
Comments Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments p-value not adjusted for multiple comparison, a priori threshold for significance set at p<0.025 for multiple comparisons.
Method Generalized Estimating Equation
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Obese With NGT-Placebo, Obese With NGT-Synbiotic
Comments Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments p-value not adjusted for multiple comparison, a priori threshold for significance set at p<0.025 for multiple comparisons.
Method Generalized Estimating Equation
Comments [Not Specified]
2.Secondary Outcome
Title Plasma Endotoxin Level and Its Panel.
Hide Description Plasma Lipopolysaccharide (LPS) after intervention period
Time Frame Change from baseline plasma endotoxin level and its panel during 28 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Poor recruitment for type 2 diabetic group means few subjects analyzed.
Arm/Group Title Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Hide Arm/Group Description:
Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Overall Number of Participants Analyzed 6 8 8 10 8 9 1 0 1
Mean (Standard Deviation)
Unit of Measure: Endotoxin units/mL
0.4452  (0.1987) 0.5634  (0.1713) 0.6925  (0.5907) 0.6230  (0.1976) 0.8012  (0.4187) 0.7195  (0.2905) 0.2961 0.4062
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obese With NGT-Placebo, Obese With NGT-Sevelamer
Comments Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments p-value not adjusted for multiple comparison, a priori threshold for significance set at p<0.025 for multiple comparisons.
Method Generalized Estimating Equation
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Obese With NGT-Placebo, Obese With NGT-Synbiotic
Comments Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments p-value not adjusted for multiple comparison, a priori threshold for significance set at p<0.025 for multiple comparisons.
Method Generalized Estimating Equation
Comments [Not Specified]
3.Secondary Outcome
Title Gut Permeability
Hide Description urine lactulose: mannitol ratio.
Time Frame Change from baseline gut permeability at 24 days of the intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
One obese sevelamer subject was not able to complete their baseline Lactulose: Mannitol ratio assay, thus cannot evaluate pre-post effect from their study.
Arm/Group Title Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Hide Arm/Group Description:
Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks
Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
Overall Number of Participants Analyzed 6 8 8 10 8 9 2 0 1
Mean (Standard Deviation)
Unit of Measure: ratio
0.02262  (0.006856) 0.02164  (0.008943) 0.02349  (0.008680) 0.02055  (0.01018) 0.01635  (0.006882) 0.01952  (0.004869) 0.02662  (0.004186) 0.01979
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obese With NGT-Placebo, Obese With NGT-Sevelamer
Comments Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments p-value not adjusted for multiple comparison, a priori threshold for significance set at p<0.025 for multiple comparisons.
Method Generalized Estimating Equation
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Obese With NGT-Placebo, Obese With NGT-Synbiotic
Comments Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments p-value not adjusted for multiple comparison, a priori threshold for significance set at p<0.025 for multiple comparisons.
Method Generalized Estimating Equation
Comments [Not Specified]
Time Frame Study participants were enrolled in the study for approximately 2-3 months.
Adverse Event Reporting Description Adverse Event data was collected over the course of the subject's participation in the study, often at followup visits as part of biopsy site checks.
 
Arm/Group Title Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Hide Arm/Group Description Lean (BMI< 26 kg/m2) normal glucose tolerant Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks Lean (BMI< 26 kg/m2) normal glucose tolerant Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Lean (BMI< 26 kg/m2) normal glucose tolerant Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Obese (BMI = 30-37 kg/m2) normal glucose tolerant. Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks. Type 2 Diabetics Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks. Type 2 Diabetics Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks Type 2 Diabetics Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
All-Cause Mortality
Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/10 (0.00%)      0/9 (0.00%)      0/9 (0.00%)      0/2 (0.00%)      0/0      0/1 (0.00%)    
Hide Serious Adverse Events
Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/10 (0.00%)      0/9 (0.00%)      0/9 (0.00%)      0/2 (0.00%)      0/0      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lean With NGT-Placebo Lean With NGT-Sevelamer Lean With NGT-Synbiotic Obese With NGT-Placebo Obese With NGT-Sevelamer Obese With NGT-Synbiotic Type 2 Diabetes-Placebo Type 2 Diabetes-Sevelamer Type 2 Diabetes-Synbiotic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      3/8 (37.50%)      4/8 (50.00%)      6/10 (60.00%)      3/9 (33.33%)      4/9 (44.44%)      1/2 (50.00%)      0/0      0/1 (0.00%)    
Blood and lymphatic system disorders                   
Intermittent edema *  0/6 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Gastrointestinal disorders                   
Nausea *  0/6 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2 0/9 (0.00%)  0 0/9 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Diarrhea *  1/6 (16.67%)  1 1/8 (12.50%)  1 1/8 (12.50%)  1 0/10 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Abdominal Bloating/Flatulence *  0/6 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 2/10 (20.00%)  2 1/9 (11.11%)  1 1/9 (11.11%)  1 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Fibromyalgia Exacerbation *  0/6 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Nervous system disorders                   
Headache/Lightheadedness *  2/6 (33.33%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 1/9 (11.11%)  1 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Renal and urinary disorders                   
Yeast Infection *  1/6 (16.67%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Pruritus *  0/6 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Surgical and medical procedures                   
Biopsy Site Pain/soreness * [1]  1/6 (16.67%)  1 1/8 (12.50%)  2 3/8 (37.50%)  3 3/10 (30.00%)  4 1/9 (11.11%)  1 2/9 (22.22%)  2 1/2 (50.00%)  1 0/0  0 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Biopsies of the vastus lateralis are obtained under local anesthesia at visit 4 and 6, before and after insulin clamp. All events expected given procedure protocol.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Dr. Nicolas Musi
Organization: San Antonio Geriatric Research, Education, and Clinical Center
Phone: (210) 562-6140
EMail: musi@uthscsa.edu
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02127125    
Other Study ID Numbers: HSC20130458H
First Submitted: April 24, 2014
First Posted: April 30, 2014
Results First Submitted: August 3, 2020
Results First Posted: September 11, 2020
Last Update Posted: September 11, 2020