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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| amy freeth, MD | Bassett Healthcare | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Phase (Control), Crossover to Treatment (Glucomannan) | 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. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Difference score, trt-control (percent) | 10 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Phase (Control) and Treatment Phase (Glucomannan) | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Freeth | Bassett Healthcare Network | 607-547-3273 | amy.freeth@bassett.org |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C022901 | (1-6)-alpha-glucomannan |
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| 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 |
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| 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. | Posted | Mean | Standard Deviation | Difference score, trt-control (percent) | 10 days |
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| 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. | Posted | Mean | Standard Deviation | Difference score, trt-control (percent) | 10 days |
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| Primary | Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL) | Difference score (trt-control) of blood glucose at 120 minutes post meal. | Posted | Mean | Standard Deviation | Difference score, trt-control (mg/dL) | 120 minutes post-meal |
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| Primary | Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) | Difference score (trt-control) of insulin level at 30 minutes post meal. | Posted | Mean | Standard Deviation | Difference score, trt-control (μU/mL) | 30 minutes post-meal |
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| Primary | Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) | Difference score (trt-control) of insulin level at 60 minutes post meal. | Posted | Mean | Standard Deviation | Difference score, trt-control (μU/mL) | 60 minutes post-meal |
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