Effects of GH and Lirglutide on AgRP

Description

This is a randomized, placebo-controlled, cross-over study with 4 arms. Healthy and GH deficient adults ages 18-45 years will be studied. Arms will consist of 21-day treatment periods and be separated by 8-week washout periods. Subjects will receive, in random order: i) GH alone, ii) GH with liraglutide, iii) liraglutide alone and iv) placebo. Each phase of the study will consist of a 7-day baseline period including 2 days of testing and 21 days on therapy with visits on days 2, 7, 14 and 21. Testing before, during and at the completion of each arm will include blood sampling and assessments of insulin resistance, energy expenditure and body composition.

Conditions

Healthy, Growth Hormone Deficiency

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Study Overview

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Study Details

Study overview

This is a randomized, placebo-controlled, cross-over study with 4 arms. Healthy and GH deficient adults ages 18-45 years will be studied. Arms will consist of 21-day treatment periods and be separated by 8-week washout periods. Subjects will receive, in random order: i) GH alone, ii) GH with liraglutide, iii) liraglutide alone and iv) placebo. Each phase of the study will consist of a 7-day baseline period including 2 days of testing and 21 days on therapy with visits on days 2, 7, 14 and 21. Testing before, during and at the completion of each arm will include blood sampling and assessments of insulin resistance, energy expenditure and body composition.

Effects of Administration of Growth Hormone, Without and With Liraglutide, on AgRP, Energy and Glucose Metabolism in Healthy and GH Deficient Humans

Effects of GH and Lirglutide on AgRP

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

New York

Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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
  • 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
  • 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Columbia University,

Study Record Dates

2028-04-30