Trial Outcomes & Findings for The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY) Gastric Bypass Surgery (NCT NCT02336438)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

10 days

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) Control: iPro® Continuous Glucose Monitor (CGM) device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Phase (Control), Crossover to Treatment (Glucomannan) n=10 Participants Control: iPro CGM device will be worn for 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. Glucomannan: 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. Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	10 participants n=99 Participants

PRIMARY outcome

Timeframe: 10 days

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.

Outcome measures

Outcome measures
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) n=10 Participants Control: iPro CGM device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Difference Score: Percent of Time Spent in Hypoglycemic State	1.2 Difference score, trt-control (percent) Standard Deviation 8.2

PRIMARY outcome

Timeframe: 120 minutes post-meal

Difference score (trt-control) of blood glucose at 120 minutes post meal.

Outcome measures

Outcome measures
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) n=8 Participants Control: iPro CGM device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)	5.25 Difference score, trt-control (mg/dL) Standard Deviation 4.39

PRIMARY outcome

Timeframe: 30 minutes post-meal

Difference score (trt-control) of insulin level at 30 minutes post meal.

Outcome measures

Outcome measures
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) n=10 Participants Control: iPro CGM device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)	-109.86 Difference score, trt-control (μU/mL) Standard Deviation 79.47

PRIMARY outcome

Timeframe: 60 minutes post-meal

Difference score (trt-control) of insulin level at 60 minutes post meal.

Outcome measures

Outcome measures
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) n=10 Participants Control: iPro CGM device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)	-8.34 Difference score, trt-control (μU/mL) Standard Deviation 13.41

SECONDARY outcome

Timeframe: 10 days

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.

Outcome measures

Outcome measures
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) n=10 Participants Control: iPro CGM device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Difference Score: Percent of Time Within Normal Blood Glucose Limits	-3.2 Difference score, trt-control (percent) Standard Deviation 7.5

SECONDARY outcome

Timeframe: 10 days

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.

Outcome measures

Outcome measures
Measure	Baseline Phase (Control) and Treatment Phase (Glucomannan) n=10 Participants Control: iPro CGM device will be worn for 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. Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours. Glucomannan: iPro CGM device will be worn for 5 days. 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/day for next 5 days and log this onto the System Patient Log. Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours. glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.
Difference Score: Percent of Time With Elevated Blood Glucose	2.0 Difference score, trt-control (percent) Standard Deviation 7.9

Adverse Events

Baseline Phase (Control) and Treatment Phase (Glucomannan)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Freeth

Bassett Healthcare Network

Phone: 607-547-3273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place