Acarbose for postprandial hypotension patients with abnormal glucose metabolism: a randomized placebo-controlled clinical trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15005996
• Date of registration: 2015-02-15
• Prospective Registration: Yes
• Primary sponsor: China-Japan Friendship Hospital
• Public title: Acarbose for postprandial hypotension patients with abnormal glucose metabolism: a randomized placebo-controlled clinical trial
• Scientific title: The study of mechanism for postprandial hypotension and drug intervention in elderly patients
• Date of first enrolment: 2015-02-15
• Target sample size: Control:25;Intervention group:25;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10459
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Wei Qiao

• Name: Wei Qiao
• Affiliation: China-Japan Friendship Hospital

Key inclusion & exclusion criteria

Inclusion criteria: The study include elder inpatients who are diagnosed with PPH concomitant with abnormal glucose metabolism at stable condition.Patients are diagnosed with PPH if
1) their postprandial systolic blood pressure decreased by =20 mmHg (1mmHg=0.133 kPa) within 2 h;
2) their preprandial fasting systolic pressure was higher than 100 mmHg and postprandial systolic blood pressure <90 mmHg, or
3) they had postprandial dizziness and syncope due to incapability to autoregulate cerebral blood flow even though their postprandial systolic blood pressure decrease was <20 mmHg.
Abnormal glucose metabolism includes type 2 diabetes and impaired glucose tolerance (IGT), which were diagnosed using the criteria published by the World Health Organization in 1999: that is, OGTT 2h PG of 7.8~11.0 mmol/L for IGT and FPG more than 7.0 mmol/L and (or) 2h PG more than 11.1 mmol/L for diabetes.
Exclusion criteria: Patients are excluded if they
1) had acarbose contraindications;
2) could not coordinate because of psychiatric symptoms or dementia;
3) had infection, fever, acute heart failure, and other stresses;
4) were using acarbose, and
5) were newly diagnosed with elderly diabetics complicated with hyperglycemia (HbA1C)> 9.0%.

Age minimum: 60
Age maximum: 100
Gender: Both

Health Condition(s) or Problem(s) studied

postprandial hypotension

Intervention(s)

Control:Placebo;Intervention group:acarbose;

Primary Outcome(s)

Blood pressure;Heart rate;glucose;the hemodynamics of superior mesenteric artery;echocardiology;insulin;glucagon;

Source(s) of Monetary Support

Health Care for Senior Officials Foundation