Pre-diabetesSTOP-GONCT01276912
Study TO Prevent Diabetes With Short-term Insulin Glargine Only
A study testing Insulin glargine and Lifestyle counseling in people with Pre-diabetes, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Insulin glargine and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,420 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Mental disorder history.
- Alcohol consumption (average 50g or more high spirits drink or 100g or more low spirits drink) or drug abuse.
- Unable or unwilling to sign informed consent.
- Cannot communicate or contact with the clinical staff.
- Unwilling to receive insulin injection therapy or conduct self-monitoring of blood glucose.
- 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).
- Any other factors that may affect compliance or adverse events reported during the research program.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, 100730
Jin-Kui Yang, M.D., Ph.D., +86-10-58268445, jinkui.yang@gmail.com
About this study
Official title: A Multicenter, Randomized, Controlled Trial to Prevent Diabetes With Short-term Insulin Glargine Treatment or Lifestyle Intervention
- 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
- Being tested
- Insulin glargine, Lifestyle counseling
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal, accompanied with a lifestyle counseling.
Lifestyle counselingBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c >= 6.5%
Measured: Two years
Secondary outcomes (2)
FPG >= 7.0 for two times in a month.
Measured: Two years
HbA1c >= 7.0%
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276912
- Sponsor's protocol ID
- STOP-GO-2010
- Acronym
- STOP-GO
- Status last verified
- Jan 2011
- First submitted
- 13 Jan 2011
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial to Prevent Diabetes With Short-term Insulin Glargine Treatment or Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT01276912
- Acronym / sponsor ID
- STOP-GO / STOP-GO-2010
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,420 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 14 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glargineInsulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal, accompanied with a lifestyle counseling. | Drug | – |
| Lifestyle counselingTo 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. | Behavioural | – |
Primary outcome
HbA1c >= 6.5%
Time frame: Two years
2 secondary outcomes
FPG >= 7.0 for two times in a month.
Time frame: Two years
HbA1c >= 7.0%
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin glargine and Lifestyle counseling in people with Pre-diabetes, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Kui Yang, M.D., Ph.D. (+86-10-58268445, jinkui.yang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c >= 6.5% (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2011.