The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY) Gastric Bypass Surgery
Hypoglycemia
About this trial
This is an interventional treatment trial for Hypoglycemia
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Baseline Phase (Control)
Treatment Phase (Glucomannan)
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.
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.