Impaired Glucose Tolerance, Metabolic Syndrome, Obesity
Conditions
Keywords
Visceral fat, Impaired glucose tolerance, Insulin resistance, Growth hormone, Thiazolidinedione
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.
Interventions
DRUGRecombinant human growth hormone; pioglitazone
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment. | — |
Countries
United States
Outcome results
None listed