Study TO Prevent Diabetes With Short-term Insulin Glargine Only

NCT01276912 | Unknown DMC

• 1 other identifier: STOP-GO-2010
• Study Type: interventional
• Target: 2,420
• Locations: 1 country
• Sites: 1

Brief Summary

• Pre-diabetes is a significant risk factor for the development of type 2 diabetes, as well as macrovascular and microvascular complication.
• Previous studies show that 50% or more loss in islet B-cell function even in Pre-diabetes phase. The early insulin therapy in pre-diabetes may be a strategy in preventing metabolic disorders and cardiovascular disease.
• The objective of this study is to find if an initial insulin glargine intervention in pre-diabetes (IGT and /or IFG) could be a strategy in preventing type 2 Diabetes.
• Pre-diabetes subjects will receive a insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal. Insulin glargine treatment will be maintained for three months thereafter to find if it can prevent diabetes.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c >= 6.5%

  Two years

Secondary Outcomes (2)

• FPG >= 7.0 for two times in a month.

  Two years

• HbA1c >= 7.0%

  Two years

Interventions

Insulin glargine DRUG

Insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal, accompanied with a lifestyle counseling.

Lifestyle counseling BEHAVIORAL

To give lifestyle guidance, specifically including low fat, low saturated fatty acids, rich in dietary fiber, salt restriction, limit alcohol diet plan to reduce the 5% to 10% of body weight, and to ensure a regular moderate physical activity at least 150 minutes per week.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants are voluntary and write informed consent 2 weeks before enrollment.
• Fasting Blood Glucose between \>= 5.6mmol/L and \<7.0mmol/L, and HbA1c between \>= 5.7% and \<6.5%.
• Both male and female aged between \>= 25 and ≤ 65 years.
• Participants have the ability to use self-monitoring devices to measure their blood glucose level and practice self-insulin injection.
• Have the ability and willingness to complete the study logs and questionnaires.
• Pregnancy test of all child-bearing age women should be negative, and they agree to adopt contraceptive measures in the study process.

You may not qualify if:

• With previous diagnosis of diabetes or application of hypoglycemic drugs.
• Preliminary screen for fasting plasma glucose lever ≥7.0mmol/L or \<5.6mmol/L.
• Preliminary screen for HbA1c result HbA1c\<5.7% or ≥ 6.5%.
• Receiving cancer treatment in the past 5 years.
• Preliminary diagnostic anti-HIV test result positive, with no serological testing.
• People with active tuberculosis.
• Persons hospitalized for heart disease and received the treatment measures (such as coronary artery bypass graft CABG, percutaneous transluminal coronary angioplasty PTCA), while not include diagnostic measures (such as percutaneous coronary angiography) in the past 6 months.
• Cardiac function evaluated by New York Heart Association criteria (NYHA) ≥ 3 cardiac function level
• Uncontrolled high blood pressure - systolic blood pressure \> 180mmHg or diastolic blood pressure \> 105mmHg after treatment.
• Stroke or transient ischemic attack episode in the past 6 months.
• With chronic hepatitis or active liver disease, or serum AST or ALT 2.5 times the upper limit of normal.
• Male serum creatinine ≥ 124μmol/L (1.4mg/dL); Female serum creatinine ≥ 115μmol/L (1.3mg/dL).
• Systemic glucocorticoids applications, but other than local, eye, and inhalation applications.
• Anemia: male hematocrit \<36.0%; female \<33.0%.
• Other chronic diseases which may lead to the expected life less than 6 years or conditions that may affect life expectancy.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jin-Kui Yang, M.D., Ph.D.

CONTACT

+86-10-58268445; jinkui.yang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2011

Record last verified: 2011-01

Locations

CN (1)