Hypoglycemia
Conditions
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
Detailed 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.
Interventions
DIETARY_SUPPLEMENTglucomannan
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.
Sponsors
Bassett Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Score: Percent of Time Spent in Hypoglycemic State | 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. |
| Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL) | 120 minutes post-meal | Difference score (trt-control) of blood glucose at 120 minutes post meal. |
| Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) | 30 minutes post-meal | Difference score (trt-control) of insulin level at 30 minutes post meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Score: Percent of Time Within Normal Blood Glucose Limits | 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. |
| Difference Score: Percent of Time With Elevated Blood Glucose | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Baseline Phase (Control), Crossover to Treatment (Glucomannan) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Phase (Control) and Treatment Phase (Glucomannan) | Difference Score: Percent of Time Spent in Hypoglycemic State | 1.2 Difference score, trt-control (percent) | Standard Deviation 8.2 |
p-value: 0.99Wilcoxon Signed Rank Test
Primary
Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)
Difference score (trt-control) of blood glucose at 120 minutes post meal.
Time frame: 120 minutes post-meal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Phase (Control) and Treatment Phase (Glucomannan) | Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL) | 5.25 Difference score, trt-control (mg/dL) | Standard Deviation 4.39 |
p-value: 0.0156Wilcoxon Signed Rank Test
Primary
Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)
Difference score (trt-control) of insulin level at 30 minutes post meal.
Time frame: 30 minutes post-meal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Phase (Control) and Treatment Phase (Glucomannan) | Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) | -109.86 Difference score, trt-control (μU/mL) | Standard Deviation 79.47 |
p-value: 0.02Wilcoxon Signed Rank Test
Primary
Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)
Difference score (trt-control) of insulin level at 60 minutes post meal.
Time frame: 60 minutes post-meal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Phase (Control) and Treatment Phase (Glucomannan) | Mixed Meal Testing: Difference Score: Insulin Level (μU/mL) | -8.34 Difference score, trt-control (μU/mL) | Standard Deviation 13.41 |
p-value: 0.13Wilcoxon Signed Rank Test
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.
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Phase (Control) and Treatment Phase (Glucomannan) | Difference Score: Percent of Time With Elevated Blood Glucose | 2.0 Difference score, trt-control (percent) | Standard Deviation 7.9 |
p-value: 0.77Wilcoxon Signed Rank Test
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.
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Phase (Control) and Treatment Phase (Glucomannan) | Difference Score: Percent of Time Within Normal Blood Glucose Limits | -3.2 Difference score, trt-control (percent) | Standard Deviation 7.5 |
p-value: 0.4922Wilcoxon Signed Rank Test