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Articles by G. Wolf
Total Records ( 7 ) for G. Wolf
  G. H Yoo , J Moon , M LeBlanc , F Lonardo , S Urba , H Kim , E Hanna , T Tsue , J Valentino , J Ensley and G. Wolf

Objective  To assess the feasibility of treating patients with high-risk stage III and IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx with perioperative adenovirus-p53 (INGN 201) gene therapy along with surgery and chemoradiotherapy.

Design and Setting  A phase 2 study in a multi-institutional setting within the Southwest Oncology Group.

Patients  Thirteen individuals who met the following entry criteria: newly diagnosed, previously untreated squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx; selected stage III or IV disease without distant metastases; and surgically resectable disease.

Interventions  Surgery, perioperative INGN 201 gene therapy, and postoperative chemoradiotherapy.

Main Outcome Measures  Overall patient status, tumor status, adverse effects, accrual rate, and percentage of patients successfully receiving the required doses of INGN 201.

Results  All 13 patients received surgery and perioperative INGN 201 injections in the primary tumor bed and the ipsilateral neck. In addition, 3 patients received injections in the contralateral neck. Three patients did not receive chemoradiotherapy. One patient had a grade 2 fistula of the oral cavity. Of the 10 patients with evaluable data, 2 experienced grade 4 adverse events, 1 owing to hypokalemia, hyponatremia, vomiting, leukopenia, and neutropenia and 1 owing to increased aspartate aminotransferase and alanine aminotransferase levels. Seven other patients experienced grade 3 adverse events. The estimate of 1-year progression-free survival is 92%.

Conclusions  This trial demonstrated the feasibility of handling and delivering a very complex gene vector safely in multiple cooperative group institutions without significant incident. Intraoperative INGN 201 gene therapy is technically feasible, but it has many logistical problems when performed in a multi-institutional setting. Regulatory requirements might have hindered accrual in this multi-institutional setting. Disease control seems to be promising; however, no definitive conclusion can be made with this small sample size.

Trial Registration Identifier: NCT00017173

  A. Samann , O. Tajiyeva , N. Muller , T. Tschauner , H. Hoyer , G. Wolf and U. A. Muller

Aims The diabetic foot syndrome (DFS) is an important complication of diabetes mellitus resulting in amputations, disability and reduced quality of life. DFS is preventable. The aim was to investigate the prevalence of the DFS at the primary care level in Germany.

Methods This was a cross-sectional study of the prevalence of DFS, associated factors and glycaemic control at the primary care level in Germany. We examined an unselected sample of participants with known diabetes who were insured by Deutsche BKK, a large healthcare insurer.

Results Three hundred and forty-one general practitioners examined 4778 participants with diabetes mellitus: 366 (7.7%) participants (mean age 49±16years) had Type 1 and 4412 participants (mean age 66±10years) had Type 2 diabetes. DFS was diagnosed in 138 patients, resulting in a prevalence of 3.6%[95% confidence interval (CI) 1.9, 6.0] in Type 1 and 2.8% (95% CI 2.3, 3.4) in Type 2 diabetes. DFS was independently associated with age, duration of diabetes, height, current smoking and insulin therapy. There was no significant effect of glycaemic control on the risk of DFS. The prevalence of other abnormal foot findings was: peripheral neuropathy 9.7%, peripheral arterial disease 14.8% (absent dorsalis pedis), 12.4% (absent tibialis posterior), acute diabetic foot ulcer 0.8%, amputations of lower extremities 1.5%, and amputations limited to toes 0.5%.

Conclusions The prevalence of the DFS at the primary care level in Germany is 2.9%. Almost 50% of patients with DFS had major or minor amputations. Common risk factors such as hyperkeratosis and poor glycaemic control can be modified. Effective therapeutic approaches in addition to methods for primary and secondary prevention of DFS should be used more widely.

  A. Samann , T. Lehmann , C. Kloos , A. Braun , W. Hunger-Dathe , G. Wolf and U. A. Muller

Aims To assess the outcome of a Diabetes Treatment and Teaching Programme (DTTP) on glycated haemoglobin (HbA1c), severe hypoglycaemia (SH) and severe ketoacidosis (SKA) in adolescents and young adults with Type 1 diabetes.

Methods Quality-assurance project with assessment of participants 1year after participation in a DTTP (5-day inpatient course, groups ≤10 patients, fixed curriculum of education/training, introduction of dietary freedom). Before–after analyses of participants aged 12–15, 15–18, 18–21 and 21–24 years. Main outcome measures were HbA1c, SH and SKA.

Results For the 1592 participants, aged 12 to 24 years, mean age at enrolment was 19±3 years, mean duration of diabetes was 7.3±5.4 (range 0.3–24) years, mean baseline HbA1c declined from 8.8±2.3% to 8.1±2.0%. The incidence of SH was 0.31 vs. 0.11 events/patient/year; the incidence of SKA 0.17 vs. 0.07 events/patient/year. In mixed effects models taking into account effects of centres, age and diabetes duration, the mean difference was −0.64%[P<0.001, 95% confidence interval (CI) −0.79 to −0.5] for HbA1c, −0.2 events/patient/year (P<0.0001, 95% CI −0.28 to −0.12) for SH and −0.1 events/patient/year (P<0.0001, 95% CI −0.14 to −0.06) for SKA.

Conclusions Adolescents and young adults with Type 1 diabetes benefit from participation in a standard DTTP for flexible, intensive insulin therapy and dietary freedom.

  N. Muller , C. Kloos , T. Frank , M. Ristow , G. Wolf and U. A. Muller
  Objective Regular human insulin is usually recommended with an injection-meal interval. It is not known how many patients follow these recommendations and, of those who do, the injection-meal interval remains incompletely studied. We investigated the injection-meal interval in patients with Type 1 and Type 2 diabetes and the association with metabolic control in routine care. Methods Four hundred and seventy-one consecutive patients with Type 1 or Type 2 diabetes were interviewed to determine their injection-meal interval in a university outpatient clinic setting in Germany in 2006. Four hundred and thirty-three interviews were suitable for analysis (143 Type 1 diabetes, 290 Type 2 diabetes). HbA1c was Diabetes Control and Complications Trial adjusted. Results Among those with Type 1 diabetes, 27% ‘always’, 27% ‘sometimes’ and 46% ‘never’ used an injection-meal interval. Forty-three per cent of patients with Type 2 diabetes always used an injection-meal interval, 12% sometimes and 45% never. Among patients with Type 1 diabetes, there was no difference in HbA1c between those who always used an injection-meal interval (n = 39, age 58 years, duration of diabetes 21.1 years, BMI 28.7 kg/m², HbA1c 7.50%/58 mmol/mol) compared with those who never used an injection-meal interval (n = 66, age 47.3 years, duration of diabetes 17.4 years, BMI 27.3 kg/m², HbA1c 7.55%/59 mmol/mol). Among patients with Type 2 diabetes, HbA1c in those who always used an injection-meal interval (n = 124, age 65 years, duration of diabetes 13.8 years, BMI 32.6 kg/m², HbA1c 7.31%/56 mmol/mol) is 0.27% lower compared with those who never used an injection-meal interval (n = 130, age 64.3 years, duration of diabetes 16 years, BMI 32.8 kg/m², HbA1c 7.58%/59 mmol/mol). Conclusion Nearly half of insulin-treated patients do not use an injection-meal interval. We found no significant association between adherence to injection-meal interval and HbA1c in patients with Type 1 diabetes, but a slightly lower HbA1c in patients with Type 2 diabetes who always use an injection-meal interval.
  T. Neumann , A. Samann , S. Lodes , B. Kastner , S. Franke , M. Kiehntopf , C. Hemmelmann , T. Lehmann , U. A. Muller , G. Hein and G. Wolf
  Aim  There are conflicting data regarding the risk of osteoporosis in patients with Type 1 diabetes. We investigated an association between diabetes, bone mineral density and prevalent fractures.

Methods  A single-centre, cross-sectional study of men and pre-menopausal women with Type 1 diabetes (n = 128) and a matched control group (n = 77) was conducted. The primary outcome measure was bone mineral density and secondary measures were markers of bone metabolism and prevalent fractures.

Results  Hip and total body bone mineral densities were significantly lower in women with diabetes compared with control subjects. In men, no difference in bone mineral density was found. A multivariate regression analysis in women with diabetes revealed higher BMI as the strongest predictor of higher total hip, femoral neck and total body bone mineral density, whereas previous fractures were inversely associated with total hip bone mineral density and C-terminal telopeptide of type I collagen with total body bone mineral density. Poor long-term glycaemic control was not associated with low bone mineral density. Fracture frequency was higher in patients with diabetes compared with control subjects (1.64 vs. 0.62 per 100 patient-years; P < 0.05). In a multivariable model, long-term HbA1c control was associated with increased clinical fracture prevalence (OR 1.92; 95% CI 1.09-2.75) in those with diabetes.

Conclusions  Type 1 diabetes contributes to low bone mineral density in women. Previous fractures and low BMI were strong predictors of impaired bone mineral density and should therefore be considered in risk estimation. Fractures are more frequent in Type 1 diabetes. Long-term hyperglycaemia may account for impaired bone strength, independently from bone mineral density.

  L. Baz , N. Muller , E. Beluchin , C. Kloos , T. Lehmann , G. Wolf and U. A. Muller
  Aim  To assess the relationship between social status and quality of diabetes care in a tertiary care centre in Germany.

Methods  Social status was assessed in 940 consecutive patients in a university outpatient department by a questionnaire. The assessment comprised three components: education, highest professional position and household net income (total score 3-21). Quality of diabetes care was measured by HbA1c, blood pressure and BMI. The influence of social status on quality measures was analysed at entry and last visit by fitting linear mixed models.

Results  At the entry visit, patients with lower social status had a higher HbA1c compared with patients with higher status (0.06% per each point of social score difference). After a mean follow- up of 6.0 years (Type 2 diabetes) and 9.4 years (Type 1 diabetes) no significant differences in HbA1c could be found. However, difference in BMI (−0.41 kg/m2 per each point of social score) persisted at last observation. Blood pressure was only negligibly affected by the care programme.

Conclusions  Low social status is associated with worse quality of diabetes care at entry in a tertiary care centre. The differences in HbA1c disappeared after treatment and structured education, whereas the difference in BMI persisted. There was no significant influence of social status or treatment on blood pressure.

  U. Ott , M. Busch , T. Steiner and G. Wolf
  In end-stage renal disease patients anemia is known to be an independent risk factor for cardiovascular disease and death. In a monocenter retrospective analysis, we investigated 207 stable patients (68 women/139 men) who underwent a first renal transplantation. Immunosuppressive therapy was performed with either cyclosporine plus mycophenolate mofetil, tacrolimus plus mycophenolate mofetil, or rapamycin plus mycophenolate mofetil; 43.5% of the patients were treated with steroids. Seventy-eight patients (37.7%) displayed anemia, including 8.7% with a severe disorder displaying an average hemoglobin (Hb) level of <6.8 mmo/L in men and <6.2 mmol/L in women. In 8.2% of the cases, we observed moderate anemia (Hb 6.8–7.4 mmol/L in men and 6.2–6.8 mmol/L in women), and in 20.8% (29 men and 14 women), mild anemia (Hb <8.06 mmol/L in men and <7.45 mmol/L in women). Erythropoietin was administered in 55.5% of patients with severe anemia, 53% with moderate anemia, and 11.6% with mild anemia. Serum creatinine level was a significant predictor of anemia (B −0.004; SE 0.001; P < .01). Among patients with creatinine >200 μmol/L, 63% were anemic compared with 22% of those with a serum creatinine level <200 μmol/L (P < .05). No correlation was observed with immunosuppressive medication or treatment with angiotensin-converting enzyme inhibitors/angiotensin-II receptor antagonists. During a 3-year follow-up, both mortality and graft failure rates were significantly greater among anemic patients nonanemic patients (mortality 3.3% vs 0.5%, P < .001; graft failure 4.3% vs 0%, P < .001). We found an unexpectedly high incidence of anemia in patients with well-functioning grafts. Anemia as a risk factor for mortality and graft failure should be treated more intensively among renal transplant patients.
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