Clinical trial NCT00352287: Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults
Official title: Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Metabolic Syndrome
Impaired Glucose Tolerance
Keywords: Visceral fat
Impaired glucose tolerance
Insulin resistance
Growth hormone
Thiazolidinedione
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to determine the effects of growth hormone and an insulin sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants received a combination of two drugs: (1) recombinant human growth hormone (or its placebo) and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar levels of participants before and after 40 weeks of treatment.

Detailed description: Treatment with recombinant human growth hormone (GH) has been shown to reduce visceral adipose tissue (VAT) and improve insulin sensitivity in normoglycemic adults, but glucose levels may rise transiently. Pioglitazone, a thiazolidinedione (TZD) drug, counters the short-term diabetogenic effect of GH in rodents, but combined use of these drugs has not been evaluated in humans.

The purpose of this study was to determine the effects of GH and a TZD, alone and in combination, on glucose metabolism, visceral adiposity and insulin sensitivity in abdominally obese adults with impaired glucose tolerance. The hypothesis that combined treatment attenuates GH-induced increases in glucose concentrations, reduces VAT, and improves insulin sensitivity over time was tested. Sixty-two adults received GH and pioglitazone for 40 weeks in a double-blind, randomized, placebo-controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age between 40 and 75 years
* BMI \> 27 kg/m2
* Waist circumference \>100 cm for men and \> 88 cm for women
* Impaired glucose tolerance (documented by a 75 gram OGTT)

Exclusion Criteria:

* Diabetes mellitus
* Malignancy
* Premenopausal women who are breastfeeding or decline contraception
* Congestive heart failure
* ALT \> 3 times upper normal limit

Primary outcomes:
measure: Visceral fat content was quantified by CT scan, glucose tolerance was assessed using a 75 gm OGTT and insulin sensitivity was measured using steady-state plasma glucose (SSPG) levels obtained during an insulin suppression test.
Secondary outcomes:
measure: Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: Andrew R Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Hamdee Y Attallah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.