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LIPP


Title Lifestyle Intervention in Preparation for Pregnancy (LIPP)
Therapeutic Area Pregnancy, Obesity
Principal Investigator Patrick M. Catalano, MD
Min Age 18 Years
Max Age 45 Years
Gender Female
Contact Patrick M. Catalano, MD
617-636-1468
More Information https://www.clinicaltrials.gov/ct2/show/NCT03146156

Overview

The aim of this study is to improve the metabolic health of overweight and obese women prior to a planned pregnancy. 

Study Details

Inclusion Criteria

  • Planning a pregnancy
  • BMI between 25 - 35
  • Willing to participate in physical activity and healthy eating

Exclusion Criteria

  • Males
  • Women of non-childbearing age
  • BMI <25 or >35

Study Requirements

  • Laboratory blood sample will be taken for routine laboratory studies - blood count, hemoglobin, A1c, thyroid, liver and kidney function studies, and a lipid profile including cholesterol, triglycerids, and HDL. The total amount of blood drawn for the first visit will be 100mL or about 7 tablespoons.
  • Indirect calorimetry for 30 minutes to determine resting metabolic rate. A clear plastic hood will be placed over the subject's head; the hood allows fresh air to flow in while a tube sends the out breath air into an instrument that measures oxygen and carbon dioxide.
  • Urine specimens.
  • Oral glucose tolerance test from blood samples (6 tablespoons) that will be obtained for fasting blood glucose (sugar) levels, followed by drinking an orange-flavored beverage that contains a known amount of glucose (sugar). Samples will be obtained at baseline 30, 60, 90, 120 and 180 minutes.
  • Body composition measurements and exercise capacity test.