Effects of GH and Lirglutide on AgRP

Launched by COLUMBIA UNIVERSITY · Dec 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two treatments—growth hormone (GH) and liraglutide—on a specific brain chemical related to appetite and energy use in healthy adults and those with growth hormone deficiency. The researchers want to see how these treatments work on their own and together, compared to a placebo (a treatment with no active ingredients). Participants will be randomly assigned to receive each treatment for 21 days, with breaks in between to allow their bodies to return to normal. Throughout the study, participants will have their blood tested and undergo assessments to measure insulin resistance, how much energy they expend, and changes in body composition.

To be eligible for this trial, participants must be healthy adults aged 18-45 or adults with diagnosed growth hormone deficiency in the same age group. Healthy participants may include those who are overweight or lean, but they should not have any serious medical conditions, be taking certain medications, or have recently lost or gained significant weight. Women must also use non-hormonal birth control if they are of childbearing age. Participants can expect visits at different stages of the trial for testing, and they will receive care and monitoring throughout the study. This research aims to provide valuable insights into how these treatments might help with growth hormone-related issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • HEALTHY SUBJECTS
• • 1. 40 healthy subjects, 20 male, 20 female, ages 18-45 yr.: (i) 20 (10 male, 10 female) who are overweight/Class 1 Obese (BMI 25-34.9) with abdominal fat accumulation (central adiposity) defined by waist circumference (WC) ≥ 102 cm in men, ≥ 88 cm in women, except in East/South Asians for whom the criteria will be WC ≥ 90 men and ≥ 80 women; (ii) 20 (10 male,10 female) who are lean (BMI 19-24.9) and not meeting these WC criteria.
• • 2. No medical conditions except being overweight/obese in half of subjects
• • 3. No prescription medication or other drug use
• • 4. On screening testing: BP\<140/\<90 mmHg, HbA1c\<5.7%, FPG\<100 mg/dL, normal IGF-1 and TSH levels.
• • 5. Premenopausal women: use of nonhormonal method of contraception
• • 6. Current non-smoker
• • GH DEFICIENT SUBJECTS
• • 1. 24 patients with isolated GH deficiency:12 males, 12 females.
• • 2. Ages 18-45 years
• • 3. Diagnosis of isolated GH deficiency based on accepted, BMI-appropriate GH stimulation test cut offs within 12 months of enrollment
• • 4. No prior GH therapy within 12 months of study enrollment
• • 5. Normal thyroid, adrenal and gonadal function documented by accepted stimulation test and clinical criteria
• • 6. Premenopausal women: use of nonhormonal method of contraception
• Exclusion Criteria:
• • HEALTHY SUBJECTS
• • 1. History of malignancy, diabetes, thyroid cancer or pancreatitis
• • 2. Recent dieting, weight change \>5%, pregnancy or lactation or heavy exercise
• • 3. Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment
• • GH DEFICIENT SUBJECTS
• • 1. DM requiring medication
• • 2. HbA1C \> 7.5
• • 3. Malignancy, pancreatitis or thyroid cancer history.
• • 4. Deficiency of other pituitary hormones, liver or renal disease
• • 5. Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment
• • 5. Recent dieting, weight change \> 5%, pregnancy, lactation or heavy exercise 6. Current smoking