Effects of growth hormone and liraglutide on appetite regulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the impact of growth hormone (GH) and liraglutide on the orexigenic neuropeptide AgRP in healthy adults and those with growth hormone deficiency. Participants aged 18-45 will undergo a randomized, placebo-controlled, cross-over design with four treatment arms: GH alone, GH with liraglutide, liraglutide alone, and placebo, each lasting 21 days with an 8-week washout period. The study will assess changes in insulin resistance, energy expenditure, and body composition through blood sampling and various tests before, during, and after each treatment phase. The goal is to determine whether GH stimulates AgRP levels and how liraglutide may influence this relationship.

Why it matters

Who can join: the full rules

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

Where it's running

• Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Pamela Freda, MD
• Email: puf1@cumc.columbia.edu
• Phone: 2123052254

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.