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Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans

PHASE4RECRUITING

This study is designed to investigate whether the sodium-glucose co-transporter-2 (SGLT-2) inhibitor Empagliflozin reduces sympathetic nervous system (SNS) activity in humans.

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Study details:

This is a randomised, double-blind, placebo controlled, cross-over study. Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. Comprehensive testing will occur after each 4 week treatment phase and will include assessment of muscle sympathetic nerve activity, cardiac and renal noradrenaline spillover to assess organ specific SNS activity.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age: 25 -65 years

(Body Mass Index) BMI≥30kg/m2

Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)

Metabolic syndrome (defined as having: obesity (BMI ≥30kg/m2 ) plus any two of the following four factors: Elevated triglycerides (Triglyceride≥ 1.7mmol/L), Reduced HDL (High - density lipoprotein) cholesterol (<1.0mmol/L in males, <1.3mmol/L in females), Elevated clinic systolic (Blood Pressure) BP ≥130 or diastolic BP ≥85mmHg, Fasting glucose ≥5.6mmol/L or type 2 diabetes.

office BP for screening purposes ≤160/90mmHg

drug naïve for at least 6 weeks prior to baseline assessment

Exclusion criteria

Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)

Secondary causes of hypertension

CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}

Heart failure NYHA (New York Heart Association) class II-IV

Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months)

unstable psychiatric condition

medication such as corticosteroids, several antidepressants and antipsychotics

Female participants of childbearing potential must have a negative pregnancy test prior to treatment

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Eligibility

Age eligible for study : 25 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2018-08-01

Primary completion: 2024-03-31

Study completion finish: 2024-12-30

Study type

OTHER

Phase

PHASE4

Trial ID

NCT03912909

Intervention or treatment

DRUG: Empagliflozin Oral Tablet [Jardiance]

DRUG: Placebo Oral Tablet

Conditions

• Type 2 Diabetes Mellitus
• Obesity
• Metabolic Syndrome

Image related to Type 2 Diabetes Mellitus

Condition: Type 2 Diabetes Mellitus, Obesity and more
DRUG: Empagliflozin Oral Tablet [Jardiance] and other drugs
Perth, Western Australia, Australia
Sponsor: Royal Perth Hospital

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Find a site

Closest Location:

Royal Perth Hospital

Research sites nearby

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Royal Perth Hospital
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Phase 1 Empagliflozin 10mg daily or placebo	DRUG: Empagliflozin Oral Tablet [Jardiance] Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases
PLACEBO_COMPARATOR: Phase2 Empagliflozin 10mg daily or placebo	DRUG: Empagliflozin Oral Tablet [Jardiance] Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Phase 1

Empagliflozin 10mg daily or placebo

DRUG: Empagliflozin Oral Tablet [Jardiance]

Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases

PLACEBO_COMPARATOR: Phase2

Empagliflozin 10mg daily or placebo

DRUG: Empagliflozin Oral Tablet [Jardiance]

Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Reduction in cardiac sympathetic nerve activity	Cardiac sympathetic nerve activity assessed by cardiac noradrenaline spillover	18 weeks
Reduction in renal sympathetic nerve activity	Renal sympathetic nerve activity assessed by renal noradrenaline spillover	18 weeks
Reduction in muscle sympathetic nerve activity	Muscle sympathetic nerve activity assessed by microneurography	18 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Reduction in ambulatory BP (blood pressure)	Blood Pressure assessed by ambulatory blood pressure monitoring	18 weeks
Reduction in central Blood Pressure	central Blood Pressure assessed by Sphygmocor XCEL	18 weeks
Change in urinary sodium excretion	Urinary sodium excretion assessed in a 24 hour urine sample	18 weeks
Change in glycemic control	Glycemic control as assessed by an oral glucose tolerance test	18 weeks

Frequently Asked Questions

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References

Clinical Trials Gov: Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans

Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans

Study details:

Eligibility criteria

Inclusion criteria

Exclusion criteria

Eligibility

Things to know

Study dates

Study type

Phase

Trial ID

Intervention or treatment

Conditions

Find a site

Research sites nearby

Study Plan

How is the study designed?

What is the study measuring?

Primary outcome

Secondary outcome

Frequently Asked Questions

References

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