Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide for low blood pressure and orthostatic hypotension.

Obesity is one of the characteristics of type 2 diabetes mellitus.

Most of the obese diabetes patients are combined with dyslipidemia or hypertension.

It had three arms (groups): "Liraglutide" and "Mitiglinide" (experimental), "Metformin" and "Mitiglinide" (active comparator) and "Mitiglinide" (active comparator).

The registry classes the interventions as drug.

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 35 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, age between 35-60 years old. Type 2 diabetes. 24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage iv diabetic nephropathy, or acute diabetic complications; type 1 diabetes; diagnosed moderate to severe sleep apnea syndrome(sas).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The low blood pressure and orthostatic hypotension participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the low blood pressure and orthostatic hypotension participants stayed in one arm throughout.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-05 with completion listed for 2016-09.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Blood Pressure change (time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks). Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) change (time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks).

It also tracked 6 secondary outcomes, for example 24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability, Hemodynamics parameters, including pulse wave velocity(PWV), 24-hours urine sodium and microalbumin, Carotid intima-media thickness(IMT,mm), Obesity parameters, including waist circumference (WC,cm) and body mass index(BMI, kg/m2) and Insulin resistance assessed by fasting serum insulin and HOMA-IR, and control rate of diabetes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 90 people with low blood pressure and orthostatic hypotension.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Low blood pressure and orthostatic hypotension research.