Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia
Conditions
Keywords
Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia, Randomized Controlled Trials
Brief summary
The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats (good and bad cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.
Detailed description
Diabetic nephropathy is the leading cause of end stage kidney disease in the United States. Patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to lipid-lowering drugs referred to as statins, will decrease LDL cholesterol and increase LDL particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal function.
Interventions
Extended release niacin 1500-2000mg once daily
OTHERPlacebo
Placebo tablets
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes * Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min using the four variable MDRD (Modification of Diet in Renal Disease Study Group) formula * Presence of microalbuminuria or proteinuria less than 3.5 g/d * Diagnosis of hyperlipidemia currently treated with a statin drug
Exclusion criteria
* Not meeting inclusion criteria * HDL-C \> 40 mg/dL for men, \> 50 mg/dL for women * TG (triglycerides) \< 150 mg/dL and \> 800 mg/dL * Documented intolerance to Niaspan or Aspirin * Treatment with other lipid-lowering agents (fibrates, BAS \[bile acid sequestrants\], or ezetimibe) * Elevated transaminases (AST or ALT \>1.3 x ULN) * Unstable type 2 diabetes (FBG \>200 mg/dL or HbA1c \>9.5%) * Known seropositivity for Hepatitis B, C, or HIV * Documented history of malignancy * Age \< 18 years * Pregnant women or nursing mothers * Inability to give informed consent * Start or change in statin dose \< 2 months ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Proteinuria | Baseline, 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extended Release Niacin Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily | 5 |
| Placebo Placebo tablets | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Extended Release Niacin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 5 | 3 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Change in Proteinuria
Time frame: Baseline, 1 year
Population: Nine participants were enrolled into this study, however baseline data is only available for 2 participants (1 from the Extended Release Niacin arm and 1 from the Placebo arm). Data was only analyzed for 2 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Release Niacin | Change in Proteinuria | 42 mg/dL |
| Placebo | Change in Proteinuria | 63 mg/dL |