Diabetes Prevention Program

The DPP's striking results tell us that millions of high-risk people can use diet, exercise, and behavior modification to avoid developing type 2 diabetes. The DPP also suggests that metformin is effective in delaying the onset of diabetes.

Program Participants and Results

Participants in the lifestyle intervention group—those receiving intensive counseling on effective diet, exercise, and behavior modification—reduced their risk of developing diabetes by 58 percent. This finding was true across all participating ethnic groups and for both men and women. Lifestyle changes worked particularly well for participants aged 60 and older, reducing their risk by 71 percent. About 5 percent of the lifestyle intervention group developed diabetes each year during the study period, compared with 11 percent in those who did not get the intervention. Researchers think that weight loss—achieved through better eating habits and exercise—reduces the risk of diabetes by improving the ability of the body to use insulin and process glucose.

Participants taking metformin reduced their risk of developing diabetes by 31 percent. Metformin was effective for both men and women, but it was least effective in people aged 45 and older. Metformin was most effective in people 25 to 44 years old and in those with abody mass index of 35 or higher (at least 60 pounds overweight). About 7.8 percent of the metformin group developed diabetes each year during the study, compared with 11 percent of the group receiving the placebo.

Future Research

Researchers will perform other analyses to try to determine the relative contribution of diet and exercise to the reduction in diabetes. The DPP was not designed to examine diet versus exercise, however, so the analyses may not provide a definitive answer. Researchers will also analyze the information from the study to try to determine how lifestyle intervention and metformin affect the development of heart and blood vessel diseases, which are more common in people with pre-diabetes and type 2 diabetes.

The DPP did not examine whether combining lifestyle changes and metformin would further reduce the risk of developing diabetes.

DPP researchers plan to continue examining the roles of lifestyle and metformin in preventing type 2 diabetes. They will also continue to monitor participants to learn more about the study's long-term effects. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is encouraging new research to look at cost-effective methods of delivering lifestyle modifications in group settings and over the Internet, as well as methods to sustain behavior change and weight loss. The National Diabetes Education Program (NDEP)—a joint project of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and more than 200 public and private organizations—will disseminate the findings and protocols stemming from the DPP.

The U.S. Government does not endorse or favor any specific commercial product or company. Trade, proprietary, or company names appearing in this document are used only because they are considered necessary in the context of the information provided. If a product is not mentioned, this does not mean or imply that the product is unsatisfactory.

Additional Information on the DPP

Press release from NIDDK on the results of the DPP

NIDDK's Questions & Answers About the DPP

NDEP

The National Diabetes Information Clearinghouse collects resource information on diabetes for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Reference Collection. This database provides titles, abstracts, and availability information for health information and health education resources. The NIDDK Reference Collection is a service of the National Institutes of Health.

To provide you with the most up-to-date resources, information specialists at the clearinghouse created an automatic search of the NIDDK Reference Collection. To obtain this information, you may view the results of the automatic search on the Diabetes Prevention Program.

If you wish to perform your own search of the database, you may access and search the NIDDK Reference Collection database online.

Trial Purpose

Diabetes is 2-5 times more common in schizophrenia and it is a preventable; but the current diabetes prevention guidelines are not suitable for implementation in the severely mentally ill population. The principles of diabetes prevention are essentially dietary regulation, increased physical activity and adjunctive use of oral anti-diabetic drugs (metformin). In a modified diabetes prevention protocol suitable for use in mentally ill population, we packaged the original guide lines with an adventure and recreation program based on principles of experiential learning, cognitive restructuring and behaviour modification. In this proposed study, we plan to evaluate the feasibility of adopting the new protocol, and examine its effectiveness in preventing diabetes.

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Five Year, Prospective, Randomized, Blinded, Controlled Trial Comparing the Efficacy of a Modified Diabetes Prevention Protocol and the Standard Comprehensive Outpatient Care in Lowering the Incidence of New Onset Diabetes Among People Treated for Schizophrenia and Are at Risk to Develop Type II Diabetes Mellitus.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Schizophrenia Drug Information available for: Metformin U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

1. Adherence/ability to run as designed /recruitment

2. Impact on modifiable diabetes risk factors

3. Impact on incidence of diabetes

Secondary Outcome Measures:

1. Adherence Rates for Diet, Exercise, Meds

2. Changes in lifestyle, Changes in eating patterns, Changes in activity patterns

3. Sustained changes in eating & activity patterns

Estimated Enrollment: 200
Study Start Date: February 2005
Estimated Study Completion Date: January 2009

Detailed Description:

Rationale:

• From large international RCT studies, Type 2 Diabetes can be prevented / delayed for overweight, pre-diabetic individuals by making basic lifestyle changes (regular moderate exercise, healthy eating habits) and using metformin or other insulin resistance inhibitor.
• Individuals with schizophrenia are in particular need of preventative intervention and conventional approaches do not match their needs.
• Research has not examined how to facilitate lifestyle changes in the lives of individuals with schizophrenia. We need to…
• Develop and evaluate innovative diabetes prevention strategies tailored to meet the needs of individuals with schizophrenia.
• Research how to make it work for pre-diabetic individuals being treated for schizophrenia.

The effectiveness of the novel intervention will be tested using a prospective, randomized, controlled clinical trial. A multi-factorial design enables a 2 x 2 analysis of the independent effects of three interventions – a tailored lifestyle modification program, metformin, and the standard conventional intervention. There is no anticipated interaction effect between metformin and lifestyle interventions. Clients currently treated for schizophrenia at a community outpatient clinic will be screened for diabetes, and those who fulfill the inclusion criteria, and give written consent, following a three week run-in period, will be randomized to one of four groups to receive either: the experimental intervention with placebo, the experimental intervention with metformin or the conventional intervention with placebo or conventional intervention with metformin.

Clinical Trial

Eligibility

Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• People who are at least 18 years old, diagnosed as having schizophrenia, confirmed through a structured clinical interview (SCID-P) for DSM IV, treated with antipsychotic drugs at least for 2 years and deemed clinically stable. Clinical stability is operationally defined as absence of a relapse warranting hospitalization in the preceding six months.
• People who are deemed as “pre-diabetics” in accordance with the diagnostic criteria established by the American Diabetic Association (ADA, 2004) as following: impaired fasting glucose (IFG) indicating fasting plasma glucose ranging between 100-125 mg/dl or 5.6 - 6.9 mmol/l.; and impaired glucose tolerance (IGT) indicating 2-h post-load glucose ranging between 140-199 mg/dl or 7.8 - 11.0 mmol/l.
• People who have gained > 10% body weight since??? Or body mass index > 24 kg/m², except Asian decent at 22 kg/m² or greater??
• Competent to provide informed consent to voluntarily participate in the study.

Exclusion Criteria:

• People who meet the criteria for diabetes, (i.e., repeat fasting blood glucose (FBG) >7 mmol/l or, 2 hr.
• post-load glucose >11.1 mmol. as determined by a 2 hr. glucose tolerance test (GTT)).
• People with evidence of clinically significant liver disease, renal or gastrointestinal impairments, as suggested by clinical history and liver and kidney functions tests. Any impairment deemed clinically significant would be a relative contra-indication for the use of metformin.
• Women in the child bearing age, who are not willing to use contraceptive measures.
• People with other comorbid disorders such as clinically significant heart or lung disease that may prevent participation in various physical activities or disorders of glucose metabolism (e.g., Cushing’s Syndrome, Acromegaly, and chronic pancreatitis).
• People with treatments that would interfere with participation or completion of the protocol (e.g., in shared care and planning to be discharged shortly from the clinic), or having a confounding effect on the measurement of the primary outcomes of the study (prescription weight loss drugs, lipid lowering agents?)
• People with weight loss >10% in past 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182494

Contacts

Contact: Lakshmi P Voruganti, MD 905-522-1155 ext 6355 vorugl@mcmaster.ca

Contact: Susan Strong, MSc 905-522-1155 strongs@mcmaster.ca

Locations

Canada, Ontario

McMaster University Recruiting

Hamilton, Ontario, Canada

Contact: Lakshmi P Voruganti, MD 905-522-1155 ext 6355 vorugl@mcmaster.ca

Contact: Susan Strong, MSc 905 522 1155 strongs@mcmaster.ca

Principal Investigator: Lakshmi P Voruganti, MD

Sponsors and Collaborators

Hamilton Health Sciences

The Lawson Foundation

Ontario Mental Health Foundation

Investigators

Principal Investigator: Lakshmi P Voruganti, MD McMaster University

Related Videos

In a two-part interview, Dr. Griffin Rodgers, director of the National Institute of Diabetes and Digestive and Kidney Diseases, discusses the risk factors for diabetes as well as a condition called pre-diabetes. The video is entitled "Questions to ask about diabetes":

More Information

No publications provided

Study ID Numbers: 04-2417
Study First Received: September 14, 2005
Last Updated: September 14, 2005
ClinicalTrials.gov Identifier: NCT00182494 History of Changes
Health Authority: United States: Food and Drug Administration; Canada: Therapeutic Products Directorate, Health Canada

Keywords provided by McMaster University:

Schizophrenia, Diabetes, Weight gain, Antipsychotic drugs

Study placed in the following topic categories:

Metabolic Diseases

Metformin

Diabetes Mellitus

Endocrine System Diseases

Antipsychotic Agents

Weight Gain

Body Weight

Schizophrenia

Additional relevant MeSH terms:

Schizophrenia

Metabolic Diseases

Mental Disorders

Endocrine System Diseases

Mental Disorders
Diabetes Mellitus, Type 2
Psychotic Disorders
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Schizophrenia and Disorders with Psychotic Features

Glucose Metabolism Disorders
Diabetes Mellitus
Schizophrenia and Disorders with Psychotic Features