Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00802971
Status:
COMPLETED
Last Update Posted:
2009-11-17
First Post:
2008-12-03
Brief Title:
Idiopathic Reactive Hypoglycaemia and Treatment With Fructo-Oligosaccharide
Sponsor:
Asker Baerum Hospital
Organization:
Asker Baerum Hospital
Study Overview
Official Title:
Prevalence of Idiopathic Reactive Hypoglycaemia and Impact of Fructo-Oligosaccharide Supplementation on Blood Glucose Variability
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Idiopathic reactive hypoglycemia IRH describes a condition where recurrent episodes of symptomatic hypoglycemia occurs one to four hours after a meal usually following meals rich in carbohydrates Differential diagnoses to be excluded include those caused by isulinomas or bariatric surgery dumping syndrome or iatrogenic induced hypoglycaemia
The prevalence of IRH is not fully known A British trial among 1136 random chosen women aged 17-50 reported that 379 experienced symptomatic hypoglycemia four times every month mean value However not all reported symptoms attributed to a low blood glucose BG correlates with measured low levels of BG and a true hypoglycaemic episode ie as defined by American Diabetes Association ADA when plasma BG value is 39 mmoll with or without accompanying symptoms This was underscored in three studies from England Canada and Denmark in whom all reported hypoglycaemic symptoms but in whom accompanying plasma glucose values 33 mmoll during hypoglycaemic symptoms only occurred in 23 47 and 0 of the study subjects respectively The majority of those with symptoms related to IRH hence are having these symptoms without being classified as hypoglycemic according to conventional interpretations However a new 2005 ADA definition relative hypoglycemia also comprise these symptomatic cases of hypoglycemia following a plasma glucose 39 mmoll
Hormonal and cerebral mechanisms tightly control the complex interplay of mechanisms involved in regulating BG concentration Explanations for IRH are centralized around increased insulin secretionsensitivity andor down regulated transcription of glucagon receptor or reduced glucagons sensitivity- and secretion Others assess an overabundance of adrenaline and cortisol witch is excreted at the nadir of the BS curve venous plasma glucose between 36 and 39 The latter event during which typical symptoms is characterized of anxiety fatigue irritability palpitations nervousness tachycardia tremor and sweat
Today treatment is limited to dietary recommendations of eating frequent meals of moderate size reasonably high in protein and with a low glycaemic load These advices keep cerebral glucose concentration stable and prohibit neuroglycopenic symptoms like hunger dizziness tingling blurred vision difficulty in thinking and faintness Pharmacologic attempts in treating IRH involves diazoxide metformin α-glucosidase inhibitor glitazones and somatostatin however none of these medications are specifically indicated for the condition
Fiber is a class of carbohydrate resistant to hydrolytic digestion in the upper bowel but fermented in the colon by bacterially produced enzymes It makes the rate of ventricular emptying increase and prolongs the bowel transit time thus having a minimal impact on BG values Inulin and oligofructose are composed of polymers of oligofructose having characteristic features different from other fibers because of their physiological and biochemical attributes Found in a variety of edible fruit and vegetables their fermentation produces short-chain fatty acids that acidify the colonic content This stimulates selectively the growth of beneficial and potentially health-promoting bifidobacteria and reduces potential harmful colon bacteria Acting as prebiotica oligofructose induces changes in the colonic epithelium and in miscellaneous colonic functions inter alia enhances calcium and magnesium absorption modulates endocrine as well as immune functions and affects the metabolism of lipids positively The latter being at a systemic level may contribute to modulating lipogenesis and reducing triglyceridemia by partially impairing hepatic cholesterol synthesis
FOS has not yet been investigated thoroughly as a possible stabilizer of blood glucose However several non-oligofructose studies using a high-fiber diet indicates reduced pre-prandial BG values less hypoglycemic cases glukosuri total cholesterol triglycerides VLDL cholesterol and area under the curve AUC in a 24 hours measurement every 2 hour of BG and insulin concentration
Clinical evaluation of safety of inulin and oligofruktose as dietary fiber has reported 20 gday of oligofructose to be well tolerated The various GI side effects identified include abdominal pain and bloating flatulence and osmotic diarrhea
Despite the fact that fiber intake is proven inversely related to hypoglycemic events possible benefits of daily FOS-supplementation have not yet been investigated systematically in persons suffering of IRH Given the estimated high prevalence of IRH it is in our aim to
1 Study the prevalence and characteristics of subjects with IRH in a relevant Norwegian study population of 414 study participants
2 Evaluating the effect of FOS supplementation on blood glucose variability
The prevalence of IRH is not fully known A British trial among 1136 random chosen women aged 17-50 reported that 379 experienced symptomatic hypoglycemia four times every month mean value However not all reported symptoms attributed to a low blood glucose BG correlates with measured low levels of BG and a true hypoglycaemic episode ie as defined by American Diabetes Association ADA when plasma BG value is 39 mmoll with or without accompanying symptoms This was underscored in three studies from England Canada and Denmark in whom all reported hypoglycaemic symptoms but in whom accompanying plasma glucose values 33 mmoll during hypoglycaemic symptoms only occurred in 23 47 and 0 of the study subjects respectively The majority of those with symptoms related to IRH hence are having these symptoms without being classified as hypoglycemic according to conventional interpretations However a new 2005 ADA definition relative hypoglycemia also comprise these symptomatic cases of hypoglycemia following a plasma glucose 39 mmoll
Hormonal and cerebral mechanisms tightly control the complex interplay of mechanisms involved in regulating BG concentration Explanations for IRH are centralized around increased insulin secretionsensitivity andor down regulated transcription of glucagon receptor or reduced glucagons sensitivity- and secretion Others assess an overabundance of adrenaline and cortisol witch is excreted at the nadir of the BS curve venous plasma glucose between 36 and 39 The latter event during which typical symptoms is characterized of anxiety fatigue irritability palpitations nervousness tachycardia tremor and sweat
Today treatment is limited to dietary recommendations of eating frequent meals of moderate size reasonably high in protein and with a low glycaemic load These advices keep cerebral glucose concentration stable and prohibit neuroglycopenic symptoms like hunger dizziness tingling blurred vision difficulty in thinking and faintness Pharmacologic attempts in treating IRH involves diazoxide metformin α-glucosidase inhibitor glitazones and somatostatin however none of these medications are specifically indicated for the condition
Fiber is a class of carbohydrate resistant to hydrolytic digestion in the upper bowel but fermented in the colon by bacterially produced enzymes It makes the rate of ventricular emptying increase and prolongs the bowel transit time thus having a minimal impact on BG values Inulin and oligofructose are composed of polymers of oligofructose having characteristic features different from other fibers because of their physiological and biochemical attributes Found in a variety of edible fruit and vegetables their fermentation produces short-chain fatty acids that acidify the colonic content This stimulates selectively the growth of beneficial and potentially health-promoting bifidobacteria and reduces potential harmful colon bacteria Acting as prebiotica oligofructose induces changes in the colonic epithelium and in miscellaneous colonic functions inter alia enhances calcium and magnesium absorption modulates endocrine as well as immune functions and affects the metabolism of lipids positively The latter being at a systemic level may contribute to modulating lipogenesis and reducing triglyceridemia by partially impairing hepatic cholesterol synthesis
FOS has not yet been investigated thoroughly as a possible stabilizer of blood glucose However several non-oligofructose studies using a high-fiber diet indicates reduced pre-prandial BG values less hypoglycemic cases glukosuri total cholesterol triglycerides VLDL cholesterol and area under the curve AUC in a 24 hours measurement every 2 hour of BG and insulin concentration
Clinical evaluation of safety of inulin and oligofruktose as dietary fiber has reported 20 gday of oligofructose to be well tolerated The various GI side effects identified include abdominal pain and bloating flatulence and osmotic diarrhea
Despite the fact that fiber intake is proven inversely related to hypoglycemic events possible benefits of daily FOS-supplementation have not yet been investigated systematically in persons suffering of IRH Given the estimated high prevalence of IRH it is in our aim to
1 Study the prevalence and characteristics of subjects with IRH in a relevant Norwegian study population of 414 study participants
2 Evaluating the effect of FOS supplementation on blood glucose variability
Detailed Description:
See above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None