Clinical trial: Macronutrients and Postprandial Vascular Function (NCT03139890)

Eligibility criteria:
Inclusion Criteria:

          -  Aged between 18-70 years

          -  Men

          -  BMI between 25-35 kg/m2 (overweight and slightly obese)

          -  Fasting plasma glucose < 7.0 mmol/L

          -  Fasting serum total cholesterol < 8.0 mmol/L

          -  Fasting serum triacylglycerol < 2.2 mmol/L

          -  Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg

          -  No current smoker

          -  No diabetic patients

          -  No familial hypercholesterolemia

          -  No abuse of drugs

          -  No more than 3 alcoholic consumptions per day

          -  Stable body weight (weight gain or loss < 3 kg in the past three months)

          -  No use of dietary supplements known to interfere with the main study outcomes as
             judged by the principal investigator

          -  No use of medication to treat blood pressure, lipid or glucose metabolism

          -  No use of an investigational product within another biomedical intervention trial
             within the previous 1-month

          -  No severe medical conditions that might interfere with the study, such as epilepsy,
             asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease,
             inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis

          -  No active cardiovascular disease like congestive heart failure or cardiovascular
             event, such as an acute myocardial infarction or cerebrovascular accident

          -  Willingness to give up being a blood donor from 8 weeks before the start of the study,
             during the study and for 4 weeks after completion of the study

          -  No difficult venipuncture as evidenced during the screening visit

        Exclusion Criteria:

          -  Women

          -  Fasting plasma glucose ≥ 7.0 mmol/L

          -  Fasting serum total cholesterol ≥ 8.0 mmol/L

          -  Fasting serum triacylglycerol ≥ 2.2 mmol/L

          -  Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg

          -  Current smoker, or smoking cessation < 12 months

          -  Diabetic patients

          -  Familial hypercholesterolemia

          -  Abuse of drugs

          -  More than 3 alcoholic consumptions per day

          -  Unstable body weight (weight gain or loss > 3 kg in the past three months)

          -  Use of dietary supplements known to interfere with the main study outcomes as judged
             by the principal investigator

          -  Use medication to treat blood pressure, lipid or glucose metabolism

          -  Use of an investigational product within another biomedical intervention trial within
             the previous 1-month

          -  Severe medical conditions that might interfere with the study, such as epilepsy,
             asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease,
             inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis

          -  Active cardiovascular disease like congestive heart failure or cardiovascular event,
             such as an acute myocardial infarction or cerebrovascular accident

          -  Not willing to give up being a blood donor from 8 weeks before the start of the study,
             during the study or for 4 weeks after completion of the study

          -  Not or difficult to venipuncture as evidenced during the screening visit
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? 0