Phase 2
Completed N=71
Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Diabetes · Metabolic Syndrome x
Source: ClinicalTrials.gov NCT01145066 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Fasting Insulin — 15.4; 19.1; 20.2 μIU/mL
Summary
This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Insulin |
17.7; 24.6; 20.6 | — |
| PRIMARY hsCRP |
3.06; 3.59; 3.72 | — |
| PRIMARY Leptin |
33.9; 40.6; 44.2 | — |
| SECONDARY Serum Fatty Acids |
.66; .62; .66; 0; 0; 0 | — |
| SECONDARY Pro and Anti-inflammatory Cytokines |
— | — |
| SECONDARY Fasting Glucose |
125.9; 128.7; 130.7 | — |
| SECONDARY Hemoglobin Levels |
6.90; 7.20; 7.07 | — |
| SECONDARY Adipose Derived Cytokines |
— | — |
| SECONDARY PBMC Gene Expression |
— | — |
| SECONDARY SNPs in DNA of Selected Genes |
— | — |
| SECONDARY PBMC Leukotriene Stimulation |
— | — |
Eligibility Criteria
Inclusion Criteria
- adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl, women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN medication 5. fasting glucose greater than or equal to 100 mg/dl.
- participants on statins or glucose lowering drugs if dosages are stable for 3 months
Exclusion criteria
- children/young adults less than 21 years of age
- currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day
- taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids OK.
- currently using niacin, fibrates or fish oil
- blood pressure greater than 170/100
- HB1Ac greater than 10%
- TG greater than 500 mg/dl
- myocardial infarction/vascular surgery/stroke within the past year
- any stage II,III,IV heart failure
- prior cholecystectomy
- end stage renal disease
- BMI less than 23 or greater than 45
- pregnancy
- alcohol use greater than 14 drinks per week
- current self reported tobacco or illicit drug use
- intolerance or allergy to fish oil
- participants taking insulin on QD or BID doses, stable for 3 months
Data sourced from ClinicalTrials.gov (NCT01145066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.