Track topics on Twitter Track topics that are important to you
This study will determine whether resting beta cells (cells in the pancreas that produce insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus (T2DM) to make insulin. Beta cells can rest by giving patients insulin shots. The study will also examine how teenagers with T2DM feel about having diabetes and explore differences between young people with and without T2DM.
This study includes patients 12 to 25 years of age with T2DM who are overweight and who were diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or who are overweight are also eligible. Candidates are screened with a medical history, physical examination and laboratory tests.
Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a pump under the skin for 2 weeks. During these two weeks, all participants have the following tests:
- Frequent blood sugar checks.
- Oral glucose tolerance test (routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution).
- Arginine stimulation to test the response of the body to arginine, a normal ingredient of food that stimulates the release of insulin. Two catheters are placed into veins in the arms, one to administer a liquid containing arginine, the other to draw the blood samples.
- Ultrasound of the blood vessels in the neck to check for hardening of the arteries.
- Metabolism test to measure the amount of oxygen used during rest. The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes.
- MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and end of the study)
- DEXA scan to determine percent body fat.
- Tests to explore quality of life and feelings about health, work or school, friends and family.
- Exercise testing on a treadmill or stationary bicycle.
- Genetic studies for information on diabetes and obesity.
Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan, psychological testing, exercise testing, and genetic testing.
Type 2 diabetes mellitus (T2DM) is a condition characterized by insulin resistance and progressive failure of the insulin-secreting beta-cells. Previously considered a disease of adults, it is now becoming increasingly prevalent in children and adolescents. Patients with childhood onset T2DM are at very high risk for diabetes-related morbidity and mortality, due to a longer life-time duration of diabetes, as well as possible increased rapidity of beta-cell failure.
In part, the impairment in insulin secretion is caused by beta-cell exhaustion due to a constant, unsuccessful attempt to compensate for the existing insulin resistance. In addition, beta-cell function is affected by glucotoxicity, generating a downward cycle of hyperglycemia leading to decreased insulin secretion, which further worsens hyperglycemia. Results from two recent studies in adults with newly diagnosed T2DM suggest that intensive insulin treatment for 2 weeks may break this cycle, resulting in significant, long-term improvement of beta-cell function. Both reports documented that approximately 50 percent of patients maintained euglycemia on diet alone at 12-month follow-up.
In this study, we will address the following questions:
1. Does short-term beta-cell rest induced by intensive insulin therapy result in prolonged improvement in beta-cell function in adolescents and young adults with T2DM compared to patients who receive conventional treatment?
2. What mechanisms underlie the improvement of beta-cell function through beta-cell rest?
In this randomized, controlled trial we will divide adolescents and young adults with T2DM of less than or equal to 2 years duration into 2 treatment groups:
Group 1 (control arm) will receive conventional therapy for T2DM (metformin plus diet and behavior modification).
Group 2 will undergo beta-cell rest using continuous subcutaneous insulin infusion (CSII) for a period of 2 weeks, in addition to conventional therapy (metformin plus diet and behavior modification).
The primary outcome will be comparison of insulin secretion (assessed at one year) in the beta-cell rest group versus the conventional group.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Metformin, Insulin, Nutrition counseling, Exercise counseling
National Institutes of Health Clinical Center, 9000 Rockville Pike
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:39:44-0400
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.
The objective of this study is to determine whether a tailored web-based system for providing feedback on walking step-counts, in combination with regular nutrition counseling, can improve...
In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used...
The purpose of this study is to evaluate the efficacy of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional in...
This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.
In the United States, 54.4 million adults report having doctor-diagnosed arthritis (1). Among adults with arthritis, 32.7% and 38.1% also have overweight and obesity, respectively (1), with obesity be...
The capacity to match carbohydrate (CHO) oxidation with CHO availability (deemed metabolic flexibility (MetFlex)) may be important for type 2 diabetes prevention. In adults, impaired MetFlex is associ...
Cardiac rehabilitation (CR) is a structured program for the prevention of secondary cardiovascular disease (CVD) and related diseases, such as hypertension, diabetes, and obesity. This study aimed to ...
Although there have been meta-analyses of the effects of exercise prehabilitation on patients undergoing colorectal surgery, little is known about the effects of nutrition-only (oral nutritional suppl...
The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavi...
Counseling during which a professional plays an active role in a client's or patient's decision making by offering advice, guidance, and/or recommendations.
Counseling conducted via electronic or other non-face-to-face interactions.
A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
An organized and comprehensive program of health care that identifies and reduces a woman's reproductive risks before conception through risk assessment, health promotion, and interventions. Preconception care programs may be designed to include the male partner in providing counseling and educational information in preparation for fatherhood, such as genetic counseling and testing, financial and family planning, etc. This concept is different from PRENATAL CARE, which occurs during pregnancy.
Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. It can be caused by the presence of INSULIN ANTIBODIES or the abnormalities in insulin receptors (RECEPTOR, INSULIN) on target cell surfaces. It is often associated with OBESITY; DIABETIC KETOACIDOSIS; INFECTION; and certain rare conditions. (from Stedman, 25th ed)