Research background: Type 2 diabetes has increased in children
There has been a substantial increase in type 2 diabetes in the pediatric population, with more than 5,000 children under the age of 20 diagnosed each year. From 2001 to 2009, type 2 diabetes increased 31 percent in 10 to 19-year-olds.
Diabetes is the most common form of diabetes
Children under the age of 20 diagnosed with type 2 diabetes each year
Increase in type 2 diabetes between 2001-2009 in 10 to 19-year-olds
Analysis of TODAY and Teens-LABS
Data from participants in the Treatment Options for Type 2 Diabetes in Adolescents in Youth (TODAY) and Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) studies were used to compare surgery with medical management of severely obese adolescents with type 2 diabetes.
The principal investigators of this study were Thomas Inge, MD, PhD, director of the Bariatric Surgery Center at Children’s Hospital Colorado and Philip Zeitler, MD, PhD, director of Pediatric Endocrinology at Children’s Colorado.
The analysis focused on:
- Weight change
- Control of type 2 diabetes
- Glycemic control
- Cardiovascular risk markers
- Kidney function
- Frequency of hospital admission during two-year follow-up
Research methods: Comparison of two clinical trials for children and adolescents with type 2 diabetes
Treatment Options for Type 2 Diabetes in Adolescents in Youth (TODAY) clinical trial
Led by Dr. Zeitler, this NIH-funded multicenter trial, which ran between 2004 and 2009, included 699 adolescents with type 2 diabetes from 15 U.S. centers. The main purpose was to discover which medical therapies worked best to achieve control of type 2 diabetes in youth. The study found:
- Almost 50 percent of teens with type 2 diabetes failed to maintain durable glycemic control, irrespective of their assigned treatment group.
- Teens who failed oral treatment needed insulin therapy after an average of 11 months in the study.
- Combining metformin with rosiglitazone improved diabetes control by 23 percent compared with metformin alone.
- After four years, the prevalence of hypertension and albuminuria tripled and elevated LDL increased 2.4-fold — both irrespective of degree of diabetes control.
The collective data suggested that youth with type 2 diabetes have increased risks for cardiovascular complications and kidney injury over time. The study also found neither metformin nor rosiglitazone stops the progression of diabetes or obesity-related comorbidities.
Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study
Led by Dr. Inge, this NIH-funded multicenter prospective outcomes study examined 242 adolescents who underwent bariatric surgery at five U.S. centers between 2007 and 2012.
Thirty Teen-LABS participants had type 2 diabetes at the time of their surgery. Data from this group of 30 was matched to a subset of approximately 65 severely obese TODAY participants.
Research results: Only the surgical group showed major weight loss and improvement in diabetes control
Weight change over two years of follow-up
Diabetes and metabolic status over 2 years of follow-up
- Mean hemoglobin A1c (HbA1c) declined from 6.8 percent to 5.5 percent (normal is <5.7 percent) at two years.
- Ninety-four percent in the group had a HbA1c value in the non-diabetic range (<6.5 percent) at two years
- The proportion of participants with an HbA1c in the ≥6.5 percent category decreased from 48 percent at baseline to 6 percent at two years.
- Nearly half (45 percent) had hypertension at baseline, which decreased to 20 percent at two years.
- Seventy-two percent had elevations of lipid levels at baseline, which decreased to 24 percent at two years.
- Mean HbA1c increased from 6.3 percent to 7.6 percent.
- Only 38 percent in the group had an HbA1c value in the non-diabetic range (<6.5 percent) at two years.
- The proportion of participants with HbA1c in the ≥6.5 percent category doubled from 35 percent at baseline to 62 percent at two years, despite intensive medical management and emphasis on medication adherence.
- Twenty-two percent of participants had hypertension at baseline, which increased to 41 percent at two years.
- Seventy-seven percent had elevations of lipid levels at baseline, compared to 73 percent at two years.
Clinical adverse events (over two years of follow-up)
- Seven of 30 participants experienced complications requiring reoperation and/or readmission.
- Six others required hospitalization (most deemed unrelated to surgery)
Research conclusion: Surgery is superior treatment for adolescent type 2 diabetes
Adolescents with severe obesity and type 2 diabetes who received medical management experienced modest weight gain, progression of type 2 diabetes and no improvement in cardiovascular risk factors after two years.
Most adolescents who underwent surgical procedures in the Teen-LABS study experienced significant weight loss, diabetes remission and improved cardiovascular risk factors and kidney function. One-fifth of these adolescents also experienced clinical events that required surgical management.
There is a critical need for more research on the long-term effects of surgery related to medical therapy, as there is not much known currently.