Zhou 2005.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RCT RANDOMISATION RATIO: equal ratio assumed (not stated in manuscript) NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: yes PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = no ANALYSIS BY INTENTION TO TREAT: No POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin group 42% F(5/12), 58% M 7/12, Insulin plus rosiglitazone 45% F (5/11), 55% M (6/11) AGE (mean years (SD)): Insulin group 51.8 (13.5), Insulin plus rosiglitazone 46.5 (12.2). ETHNIC GROUPS (%): not stated DURATION OF DISEASE (median years (min‐max)): Insulin = 0.8 (0.3‐4.0), Insulin + rosiglitazone =1.8 (0.1‐5.0) INCLUSION CRITERIA: (1) diabetes diagnosed according to the report of WHO 1999 (2) age at onset over 25 years old (3) no ketosis within the first six months of diagnosis (4) disease duration less than five years (5) GAD‐Ab positive testing twice within one month (6) FCP level of 0.3nmol/L or more. EXCLUSION CRITERIA: impaired liver, kidney or heart function or other severe diseases. DIAGNOSTIC CRITERIA: diabetes according to the report of WHO 1999 with GAD‐Ab positive twice within one month CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin 12, Insulin + rosiglitazone 11 LOSS TO FOLLOW‐UP: 14/22 follow‐up to 18 months or 36% lost to follow‐up. |
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| Interventions |
NUMBER OF STUDY CENTRES:not reported COUNTRY/ LOCATION: China SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Insulin + rosiglitazone. Premixed human insulin (Novolin 30 R or Humulin 70/30) was injected twice a day. Rosiglitazone 4 mg/day. Diet advice CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Insulin. Premixed human insulin (Novolin 30 R or Humulin 70/30) was injected twice a day. Diet advice TREATMENT BEFORE STUDY:None TITRATION PERIOD: None. |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication):Not stated but objectives states "we hypothesized that thiazolidinediones combined with insulin in LADA may have and additional benefit on islet beta cell function" SECONDARY OUTCOMES (as stated in the publication):Not stated ADDITIONAL OUTCOMES: Collected at baseline, 6 12 and 18 months. 1. Fasting C‐peptide (nmol/L), 2. Insulin dose (U/day), 3. HbA1c (%), 4. Fasting C‐peptide (nmol/L), 5. C‐peptide after 2h 75‐g glucose load (nmol/L). |
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| Study details |
DURATION OF INTERVENTION: 18 months DURATION OF FOLLOW‐UP: 18 months. All 23 patients followed‐up for 6 months, but only 17 for 12 months and 14 for 18 month RUN‐IN PERIOD: None |
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| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: yes NON‐COMMERCIAL FUNDING: yes PUBLICATION STATUS (PEER REVIEW JOURNAL): yes PUBLICATION STATUS (JOURNAL SUPPLEMENT): no PUBLICATION STATUS (ABSTRACT): no |
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| Stated aim for study | Quote "we hypothesized that LADA patients might benefit from thiazolidinediones treatment" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Unblinded |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No evidence the analyst was blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | ITT not described, no description of dealing with missing data |
| Selective reporting (reporting bias) | Low risk | No problems identified |
| Other bias | High risk | Funded by grant from Glaxo‐SmithKline Investment Co. |