| Approved on: | 2024-11-12 |
| Brief purpose of the study: | The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) or a family history of type 2 diabetes. |
| Brief summary of what participants will be asked to do: | All procedures are for research purposes only and will be performed at the University of Missouri in Columbia. Visits will be conducted in the Clinical and Translational Science Unit (CTSU). There will be two cohorts: women with or without a history of gestational diabetes AND women/men with or without a family history of type 2 diabetes in a first degree relative. Participants will be compensated for their study involvement.
Overview of this study
• Screening Visit: You will be asked to complete the screening evaluation after you have given informed consent to determine your eligibility for this study. The research team will discuss the inclusion and exclusion criteria with you during the consenting and medical screening process. Only people who meet the eligibility criteria from the tests performed during the screening visit will be asked to continue.
• Metabolic Testing Visit 1 with Body Composition Assessment and Growth Hormone Administration: You will complete a study visit that includes an overnight stay in the clinical research unit and lasts about 24 hours. You will complete a frequently sampled oral glucose (sugar) tolerance test and blood samples will be obtained. An IV will be placed and tracer solutions will be infused. A registered nurse will administer an injection of growth hormone and teach you how to self-administer injections. Your body fat and lean mass will be determined by using a dual energy X-ray (DEXA) machine.
- Daily self-administered medication with brief electronic survey: Once per day x 6-8 days. You would inject a medication (growth hormone) underneath the skin once per day for 6-8 days and fill out a daily brief electronic survey to document this.
-Metabolic Testing Visit 2: You will complete a study visit that includes an overnight stay in the clinical research unit and lasts about 20 hours. You will complete a frequently sampled oral glucose (sugar) tolerance test and blood samples will be obtained. An IV will be placed and tracer solutions will be infused. |
| Basic eligibility criteria: | Age 18-45 years old, without current pre-diabetes or diabetes, body mass index (BMI) 30.0-44.9, not pregnant/breastfeeding, no major medical concern, stable weight (no loss or gain in last 3 months)
Group-specific criteria:
-Gestational diabetes group- female with a full term pregnancy with one baby in the last 5 years, diagnosed with gestational diabetes or NOT diagnosed with gestational diabetes
-Family history of type 2 diabetes group- male or female, a first degree relative (ex: mother, father, sibling) diagnosed with type 2 diabetes or NOT diagnosed with type 2 diabetes |
| Study contact for more information: | Heather McHatton RN at heathermchatton@health.missouri.edu |
| IRB Number: | 2111127 MU |
