Obesity, Weight Loss, and Cardiovascular Disease Risk

Trial ID or NCT#



not recruiting iconNOT RECRUITING


The goal of the study is to define the roles played by resistance to insulin-mediated glucose disposal (insulin resistance) and circulating plasma insulin concentrations in: 1) ability to lose weight; 2) reduction of risk for coronary heart disease as a result of weight loss. We hypothesize that in the setting of caloric restriction, manipulating endogenous insulin concentrations will not alter ability of subjects to lose weight, but will lead to different reduction in CHD risk factors. To test this hypothesis, two parallel studs will be performed. First, obese insulin-resistant individuals will be randomized to one of two equally-hypocaloric diets that vary moderately in proportion of carbohydrate and mono/polyunsaturated fats (lower carbohydrate diet will be associated with greater reduction in endogenous insulin secretion). Second, diabetics treated with insulin secretagogues will be compared to diabetics treated with insulin sensitizers with respect to the same outcomes (secretagogues increase insulin secretion and insulin sensitizers decrease insulin concentrations). Endpoints include weight loss, change in insulin resistance, blood pressure, lipid and lipoproteins, markers of endothelial function, daylong insulin and glucose concentrations: these will be compared, in each of the parallel studies, between the group with insulin-stimulating intervention vs the group with the insulin-sparing intervention.

Official Title

GCRC-CAP-Tracey McLaughlin, MD

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * BMI 30-35* age 35-65* nondiabetic by fasting plasma glucose concentration* no active major organ diseases* insulin resistant or insulin sensitive
Exclusion Criteria:
  1. * anemia* pregnant* major organ disease* active malignancy* eating disorder* active psychiatric illness* chronic inflammatory conditions


Tracey McLaughlin
Tracey McLaughlin
Professor of Medicine (Endocrinology)

Contact us to find out if this trial is right for you.


Cindy Lamendola, RN, MSN