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Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
Phase 2 trial testing Sevelamer in Insulin Sensitivity in 20 participants. Completed in 30 March 2020.
| Lead sponsor | The University of Texas Health Science Center at San Antonio |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 2 April 2014 |
| Primary completion | 23 February 2018 |
| Estimated completion | 30 March 2020 |
| Sites | 1 location across United States |
The University of Texas Health Science Center at San Antonio
Adults 18 to 65, any sex, with Insulin Sensitivity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Skeletal muscle insulin sensitivity measured after 28 days of low fat diet and drug intervention. The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 6.5 | ± 0 |
| Sevelamer | 8.2 | ± 2.4 |
| Synbiotic | 9.8 | ± 0.6 |
Skeletal muscle insulin sensitivity measured after 28 days of high fat diet. The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 6.8 | ± 0 |
| Sevelamer | 8.5 | ± 1.87 |
| Synbiotic | 8.8 | ± 1.63 |
Time frame: Adverse Event Data was collected over the course of the study intervention period, beginning with subject's enrollment into study and ending once they completed all visits. This period takes approximately 6 months from screening to completion of all visits.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Sevelamer | Synbiotic |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Hematoma | Surgical and medical procedures | — | — | — |
| Mouth Ulcers | Gastrointestinal disorders | — | — | — |
| Ear Itching | Ear and labyrinth disorders | — | — | — |
| Abdominal Bloating/Flatulence | Gastrointestinal disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Vasovagal Syncope | Surgical and medical procedures | — | — | — |
| Dehydration | General disorders | — | — | — |
| Gum Infection | Gastrointestinal disorders | — | — | — |
Data from ClinicalTrials.gov NCT02124759 adverse events section.
The purpose of this study is to determine insulin sensitivity in individuals that are lean normal glucose tolerant subjects after consumption of a normal low fat diet and after a high fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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