The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY) Gastric Bypass Surgery

Hypoglycemia Clinical Trial

Official title:

The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With RNY Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336438
• Other study ID #: 1036
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2015
• Last updated: August 20, 2015
• Start date: May 2013

Study information

• Verified date: August 2015
• Source: Bassett Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Currently there are no therapeutic guidelines and no proven therapy available to reduce hypoglycemic episodes post RNY gastric bypass. A study done in 1988 (n=8/ patients with partial gastrectomy and hypoglycemia) showed improvement in plasma glucose level and peak insulin response in patients suffering from this complication and who were given Glucomannan soluble fiber with a standard meal. Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant. The konjac glucomannan is the most viscosity food gum in nature. It has about ten times the viscosity than the cornstarch. Unfortunately no further studies have been done so far to validate or support this therapy in patients with RNY gastric bypass. This study will be the first one to see effectiveness of Glucomannan, exclusively in patients who are post RNY gastric bypass and have a diagnosis of postprandial hypoglycemia.

Visit 1: consent and screening bloodwork: Thyroid Stimulating Hormone (TSH), Free T4, Cortisol, Creatinine, and Insulin-like Growth Factor (IGF)

Visit 2: iPro Continuous glucose monitor (CGM) device will be placed and will be worn for next 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log (included).

Subjects will undergo a mixed meal tolerance test (MMTT), a, which includes consumption of a after a standard meal (Boost) and scheduled blood draws over 3 hours.

Visit 3: The subject will return to the research coordinator for the iPRO® Continuous Glucose Monitor (CGM) removal and data download from the device. After physical exam and vital sign measurement, a new iPro® CGM device will be placed and will be worn for next 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log (included)

Subjects will undergo a MMTT, which includes consumption of a after a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.

For the next five days subjects will take 5 grams (1 teaspoon) of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.

Visit 4: The subject will return to see the research coordinator for the CGM removal and data download from the device. At this time the study is completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: >18 year

2. Have undergone RNY Gastric Bypass >1 year.

3. 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:

1. Patient with Diabetes Type 1 or Type 2. Information identified during history taking or subject undergoing treatment of active diabetes.

2. Patient on medications or treatment (insulin, metformin, glyburide, diazoxide, octreotide, calcium channel blockers), which can cause hypoglycemia.

3. Patients with disorders, which can cause hypoglycemia, like untreated hypothyroidism, adrenal insufficiency, and growth hormone deficiency.

4. Complications of RNY i.e. Ulcers and hernia.

5. Current use of glucocorticoids or medications known to affect blood glucose levels.

6. Any patient that is unable to comply with dietary recommendations, technical iPro, glucometer actions or any part of the research protocol

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Dietary Supplement:
• glucomannan
Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant. It will be given during the Intervention Phase in conjunction with the MMTT and then for 5 days at home with meals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bassett Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Score: Percent of Time Spent in Hypoglycemic State	Percent of time within hypoglycemic blood glucose range (bg<70) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg<70 in treatment condition minus % time with bg<70 in control condition.	10 days	Yes
Primary	Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)	Difference score (trt-control) of blood glucose at 120 minutes post meal.	120 minutes post-meal	No
Primary	Mixed Meal Testing: Difference Score: Insulin Level (µU/mL)	Difference score (trt-control) of insulin level at 30 minutes post meal.	30 minutes post-meal	No
Primary	Mixed Meal Testing: Difference Score: Insulin Level (µU/mL)	Difference score (trt-control) of insulin level at 60 minutes post meal.	60 minutes post-meal	No
Secondary	Difference Score: Percent of Time Within Normal Blood Glucose Limits	Percent of time within normal blood glucose limits (bg 70-140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time within normal limits in treatment condition minus % time within normal limits in control condition.	10 days	No
Secondary	Difference Score: Percent of Time With Elevated Blood Glucose	Percent of time within hyperglycemic blood glucose range (bg>140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg>140 in treatment condition minus % time with bg>140 in control condition.	10 days	No