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

NCT02336438 | Completed Phase 4 Results

• 1 other identifier: 1036
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• Difference Score: Percent of Time Within Normal Blood Glucose Limits

  10 days

• Difference Score: Percent of Time With Elevated Blood Glucose

  10 days

Study Arms (2)

Baseline Phase (Control)

NO INTERVENTION

iPro CGM device 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 MMTT, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.

Treatment Phase (Glucomannan)

EXPERIMENTAL

iPro CGM device 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 MMTT, which includes consumption of 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 the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.

Dietary Supplement: glucomannan

Interventions

glucomannan DIETARY_SUPPLEMENT

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.

Treatment Phase (Glucomannan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bassett Healthcare: lead

MeSH Terms

Conditions

Hypoglycemia

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Amy Freeth
• Organization: Bassett Healthcare Network

amy.freeth@bassett.org

607-547-3273

Study Officials

• amy freeth, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician - Endocrinology

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 13, 2017
• Results First Posted: September 21, 2015

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share