Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186
Vancouver, British Columbia, V5Z 1M9, Canada
NCT Number: NCT01914133
The current proposal will determine if blocking carbohydrate intake in the small intestine with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension (a drop of blood pressure after eating), which can result in falls.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Phase 2
Vancouver, British Columbia, V5Z 1M9, Canada
Blocking the absorption of carbohydrates at the brush border of the small intestine with acarbose (an alpha-glucosidase inhibitor) seems a promising possibility as a potential therapeutic agent. Although designed as a second-line diabetes drug, this medication has very little risk of hypoglycemia in older adults. In fact the risk of hypoglycemia is extremely low even in patients concurrently taking concurrent hypoglycemia agents (including insulin), and there is almost no risk of hypoglycemia in subjects not on other diabetes medications. Acarbose suppresses postprandial glycemia by slowing small intestinal digestion and absorption of carbohydrate, and has been shown to slow gastric emptying Acarbose has yet to be examined in a prospective fashion in older adults, despite the prevalence of PPH in this patient population. Preliminary, pilot work done in our laboratory on older adults with PPH has demonstrated that the hypotensive response over 90 minutes to a standardized meal was significantly reduced by the administration of acarbose
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.
Other names: Glucobay, Precose, Prandase, Alpha-glucosidase inhibitor
Placebo given prior to meal the standardized meal
Other names: Bayer Material No: 02839265, Acarbose Placebo Tablet
Time frame: 2 years
The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal will be compared between n=30 subjects with PPH and n= 30 subjects without PPH.
Time frame: 2 years
The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH
Time frame: 2.5 years
The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal between the Acarbose group and the Placebo group will be compared.
Time frame: 1 day
Starting the day following each meal test, each subject with PPH will take either acarbose 25 mg po tid (prior to each meal) or placebo po tid for one day. During this 24 hour period, each subject will undergo 24 Hr-ABPM (starting at 7 ante meridian (AM) the following day). Each subject will have ambulatory blood pressure monitoring (Welch-Allyn, ABPM 6100S) performed for 24 hours. Each subject will carry a logbook to record time of activity and all meals. Each subject will be given a watch synchronized to the 24-hour blood pressure monitor.
Kenneth Madden
Other
Acronym: PPH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07728552
Arrhythmia, Arrhythmias, Cardiac
Seoul, South Korea
View Trial DetailsNCT06526884
AKI - Acute Kidney Injury, Acute Kidney Injury
Los Angeles, California, United States
View Trial DetailsNCT07118124
Arrhythmia, Arrhythmia in Children
Washington D.C., District of Columbia, United States
View Trial DetailsNCT06133075
Autonomic Nervous System Diseases, Chronic Orthostatic Intolerance
Los Angeles, California, United States
View Trial Details