RECRUITING

Effects of GH and Lirglutide on AgRP

Conditions

Healthy Growth Hormone Deficiency growth hormone liraglutide AgRP

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-01

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05681299

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.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Pamela Freda, MD

CONTACT

2123052254

puf1@cumc.columbia.edu

Rosa Lazarte

CONTACT

2123054921

rl2345@cumc.columbia.edu

Study Locations (Sites)

Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2023-05-01

Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

growth hormone
liraglutide
AgRP

Additional Relevant MeSH Terms

Healthy
Growth Hormone Deficiency