Effect of the diabetes medication, Ozempic, to reduce blood pressure falls after a meal in older people
Establishing the potential of the long-acting GLP-1 receptor agonist, semaglutide, as a treatment for postprandial hypotension (PPH) in older people – SAGE-PPH.
The University of Adelaide
32 participants
Jan 27, 2025
Interventional
Conditions
Summary
Falls in blood pressure after a meal (called postprandial hypotension) occurs commonly in people over the age of 65 years and currently has no suitable treatment. The study will determine the effects of 12 weeks treatment with the 'long-acting' glucagon-like peptide-1 (GLP-1) agonist, semaglutide once weekly (QW), also known as Ozempic, on the rate of stomach emptying, glycaemia, blood pressure (BP) and heart rate (HR) following ingestion of a glucose drink, in people over the age of 65 years who experience postprandial hypotension. This is a randomised parallel designed study. Subjects recruited into the study who pass screening criteria will be randomised to receive semaglutide QW or matching placebo. They will have a gastric emptying study performed using the gold standard technique (scintigraphy) at baseline and 12 weeks. Immediately following the first gastric emptying study they will commence treatment with semaglutide QW or Placebo, administered subcutaneously at weekly intervals. Blood pressure, heart rate, splanchnic blood flow, appetite sensations, blood glucose and gut hormones will be assessed during each of the gastric emptying measurements. Food intake for 30 min at a buffet meal will be assessed immediately following the gastric emptying study ie ~120-150 min after the gastric emptying studies. This study will help determine if semaglutide (Ozempic) can be useful in treating postprandial hypotension. We hypothesise that semaglutide (Ozempic) will slow the rate of gastric emptying and, hence, reduce the magnitude of the fall in BP after ingesting a glucose drink.
Eligibility
Inclusion Criteria4
- Male or female participants aged 65 – 80 years
- Body mass index (BMI) 25 – 40 kg/m2
- Haemoglobin and ferritin in the normal range for gender and age.
- Participant has provided written informed consent
Exclusion Criteria26
- Evidence of renal disease (i.e. a creatinine clearance cut-off of < 50 ml/min. Calculated creatinine clearance will be determined as follows using the Cockcroft-Gault equation: Cr clearance = [140 - age (years) x weight (kg)] / [0.814 x serum creatinine (µmol/L)] (For female subjects, multiply Cr clearance x 0.85)(11)
- Diagnosed with Diabetes type 1 or 2 or glycated haemoglobin (HbA1c) >/= 7mmol/L
- Iron stores, or liver function tests outside the following ranges:
- Alanine aminotransferase (ALT) < 55 U/L
- Alkaline phosphatase (ALP) 30 - 110 U/L
- Aspartate transaminase (AST) < 45 U/L
- Total bilirubin 6 - 24 µmol/L
- Haemoglobin 115 – 155 g/L (Females)
- – 172 g/L (Males)
- Ferritin 15 – 200 µg/L (Females)
- – 300 µg/L (Males)
- Hepatic or cardiovascular disease, pancreatitis (subjects with past history of acute or chronic pancreatitis, gastric surgery, or known gastroparesis on history or screening biochemistry tests.
- Participants with any history of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to screening will be excluded.
- History of any clinically significant disease or disorder which may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study.
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- History of hyperthyroidism or uncontrolled hypothyroidism.
- Chronic gastrointestinal symptoms as assessed by questionnaire.
- Use of drugs potentially affecting gastrointestinal motility (corticosteroids; anti-emetics (dopamine antagonists, 5HT-3 receptor antagonists), laxatives, prokinetic agents, anticholinergic agents, cholinergic agents, opioid medications, erythromycin).
- Current use of anticoagulants.
- Inability to abstain from smoking for 12 hours prior to the gastric emptying tests.
- Consumption of >2 units alcohol daily on a regular basis.
- Known or suspected history of alcohol or drug abuse, as judged by the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to semaglutide or drugs with a similar chemical structure or its components.
- Baseline systolic blood pressure (SBP) < /= 100mmHg
- Participation in any research studies involving exposure to ionising radiation exceeding 3.5mSv in the previous 12 months
- Donated blood in the past 3 months
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Interventions
Semaglutide 0.25-1mg or matching placebo once weekly subcutaneously for 12 weeks. Semaglutide will be uptitrated from 0.25mg for 4 weeks, followed by 0.5mg for 4 weeks and then 1mg for 4 weeks. All weekly injections will be administered by a member of the study team to guarantee adherence to the study medication. The team member will be unblinded to the treatment and not involved in any aspect of the data acquisition. A gastric emptying study using the gold standard technique (scintigraphy) will be performed by a qualified nuclear medicine technologist, at baseline (ie before treatment), at 12 weeks after commencing semaglutide. Following an overnight fast (14h solids, 12h liquids), participants will consume a 75g glucose drink (300ml) radiolabelled with 20 MBq 99mTc-DTPA to measure gastric emptying using scintigraphy. Fasting requirements will be confirmed prior to administration of the test drink.
Locations(1)
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ACTRN12625000080426