Study TO Prevent Diabetes With Short-term Insulin Glargine Only (STOP-GO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Beijing Tongren Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT01276912
First received: January 13, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose
  • 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.

Condition Intervention
Pre-diabetes
Drug: Insulin glargine
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Controlled Trial to Prevent Diabetes With Short-term Insulin Glargine Treatment or Lifestyle Intervention

Resource links provided by NLM:


Further study details as provided by Beijing Tongren Hospital:

Primary Outcome Measures:
  • HbA1c >= 6.5% [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG >= 7.0 for two times in a month. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • HbA1c >= 7.0% [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2420
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Insulin glargine
    Insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal, accompanied with a lifestyle counseling.
    Behavioral: Lifestyle counseling
    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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. With previous diagnosis of diabetes or application of hypoglycemic drugs.
  2. Preliminary screen for fasting plasma glucose lever ≥7.0mmol/L or <5.6mmol/L.
  3. Preliminary screen for HbA1c result HbA1c<5.7% or ≥ 6.5%.
  4. Receiving cancer treatment in the past 5 years.
  5. Preliminary diagnostic anti-HIV test result positive, with no serological testing.
  6. People with active tuberculosis.
  7. 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.
  8. Cardiac function evaluated by New York Heart Association criteria (NYHA) ≥ 3 cardiac function level
  9. Uncontrolled high blood pressure - systolic blood pressure > 180mmHg or diastolic blood pressure > 105mmHg after treatment.
  10. Stroke or transient ischemic attack episode in the past 6 months.
  11. With chronic hepatitis or active liver disease, or serum AST or ALT 2.5 times the upper limit of normal.
  12. Male serum creatinine ≥ 124μmol/L (1.4mg/dL); Female serum creatinine ≥ 115μmol/L (1.3mg/dL).
  13. Systemic glucocorticoids applications, but other than local, eye, and inhalation applications.
  14. Anemia: male hematocrit <36.0%; female <33.0%.
  15. Other chronic diseases which may lead to the expected life less than 6 years or conditions that may affect life expectancy.
  16. Mental disorder history.
  17. Alcohol consumption (average 50g or more high spirits drink or 100g or more low spirits drink) or drug abuse.
  18. Unable or unwilling to sign informed consent.
  19. Cannot communicate or contact with the clinical staff.
  20. Unwilling to receive insulin injection therapy or conduct self-monitoring of blood glucose.
  21. Unsatisfied control of thyroid disease - subjects who are suffering thyroid disease or receiving anti-thyroid drugs or thyroid hormone treatment, show the sensitive TSH abnormalities (except for patients with low TSH who have the history of thyroid tumor or thyroid cancer receiving the inhibitor treatment).
  22. Any other factors that may affect compliance or adverse events reported during the research program.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276912

Contacts
Contact: Jin-Kui Yang, M.D., Ph.D. +86-10-58268445 jinkui.yang@gmail.com

Locations
China
Beijing Tongren Hospital Recruiting
Beijing, China, 100730
Contact: Jin-Kui Yang, M.D., Ph.D.    +86-10-58268445    jinkui.yang@gmail.com   
Sponsors and Collaborators
Beijing Tongren Hospital
  More Information

No publications provided

Responsible Party: Jin-Kui Yang/Professor, Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT01276912     History of Changes
Other Study ID Numbers: STOP-GO-2010
Study First Received: January 13, 2011
Last Updated: January 13, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014