Phase 4
N=11
The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY) Gastric Bypass Surgery
Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT02336438 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Difference Score: Percent of Time Spent in Hypoglycemic State — 1.2 Difference score, trt-control (percent) — p=0.99
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- glucomannan (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bassett Healthcare
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Score: Percent of Time Spent in Hypoglycemic State |
1.2 | 0.99 |
| PRIMARY Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL) |
5.25 | 0.0156 sig |
| PRIMARY Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) |
-8.34 | 0.13 |
| PRIMARY Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) |
-8.34 | 0.13 |
| SECONDARY Difference Score: Percent of Time Within Normal Blood Glucose Limits |
-3.2 | 0.4922 |
| SECONDARY Difference Score: Percent of Time With Elevated Blood Glucose |
2.0 | 0.77 |
Summary
One of the emerging complications of RNY gastric bypass surgery is mild to severe refractory/ recurrent postprandial hypoglycemia. This complication can lead to a significant reduction in quality of life to severe disability. Unfortunately at this time there are no treatment guidelines or proven therapeutic options for the treatment of this complication. One of the proposed treatment options is the use of fiber supplements to help modify the absorption of glucose, slow the food bolus transit time more toward normal and restore the postprandial (after meal) glucose homeostasis. The investigators are proposing a pilot project for the use of Glucomannan soluble fiber as a treatment option for postprandial hypoglycemia in this cohort. This project will help the investigators to identify if Glucomannan soluble fiber can be used as an effective dietary supplement to eliminate or reduce this condition
Eligibility Criteria
Inclusion Criteria
- Age: >18 year
- Have undergone RNY Gastric Bypass >1 year.
- Have symptoms of hypoglycemia (altered mental status or level of consciousness, with or without seizure, palpitations, tremor, anxiety/arousal, sweating, hunger, paresthesias, behavioral changes, fatigue, confusion), documented hypoglycemia (blood glucose<70 mg/dl), hypoglycemic unawareness (recurrent hypoglycemia without symptoms).
Exclusion Criteria
- Patient with Diabetes Type 1 or Type 2. Information identified during history taking or subject undergoing treatment of active diabetes.
- Patient on medications or treatment (insulin, metformin, glyburide, diazoxide, octreotide, calcium channel blockers), which can cause hypoglycemia.
- Patients with disorders, which can cause hypoglycemia, like untreated hypothyroidism, adrenal insufficiency, and growth hormone deficiency.
- Complications of RNY i.e. Ulcers and hernia.
- Current use of glucocorticoids or medications known to affect blood glucose levels.
- Any patient that is unable to comply with dietary recommendations, technical iPro, glucometer actions or any part of the research protocol
Data sourced from ClinicalTrials.gov (NCT02336438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.