Authors
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Jones, Wendy, Golini, Jeff -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2016
INTERVENTION: Part 1: After an 8‐hour fast (minumum), normal and pre‐diabetic volunteers are randomized to one of two groups. Group 1: Participants receive 50g KarboLyn® Group 2: Participants receive 50g glucose Following consumption of the study sugar, participants are asked to walk on a treadmill ( 1mph) for a period of 2 hours. At baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, and 120 minutes, participants stop and have blood samples drawn in order to measure blood glucose levels. Part 2: All diabetic volunteers are withdrawn from their oral diabetic medication for one cycle and fast for a minimum of 8 hours prior to commencement of the study. All participants receive KarboLyn® (10 grams) and are then asked to walk on a treadmill ( 1mph) for a period of 2 hours. At baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, and 120 minutes, participants stop and have blood samples drawn in order to measure blood glucose levels. After one week ‘off’, the same volunteers are treated in the above manner prior to receiving 10 grams of glucose. Blood draw conditions and timing are the same. CONDITION: Diabetes ; Nutritional, Metabolic, Endocrine ; Diabetes PRIMARY OUTCOME: Blood sugar is measured by blood draws and standard glucose testing at ‘0’ (before consumption), and at 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, and 120 minutes for all volunteers. SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: Part 1: Healthy volunteers: 1. Aged 21 years and over 2. Healthy (not a pre‐diabetic or diabetic) 3. Normal blood sugar level (fasting glucose is less than or equal to 100 mg/dl) Pre‐diabetics: 1. Aged 21 years and over 2. Pre‐diabetic not currently taking any diabetic related medication to control blood sugar level 3. Fasting blood sugar is greater than 100 mg/dl and less than 130 mg/dl Part 2: 1. Aged 21 years and over 2. Diabetic (fasting blood sugar is between 125 mg/dl and 200 mg/dl)
Epistemonikos ID: 9ff1cb4ea778667af22e127e6f24bd177c96cd18
First added on: Aug 24, 2024