Trial document





This trial has been registered retrospectively.
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  DRKS00000695

Trial Description

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Title

Delay of Impaired Glucose Tolerance by a Healthy Lifestyle Trial
(healthy living - avoid diabetes)

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Trial Acronym

DELIGHT

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URL of the Trial

http://www.studienzentrum-online.info/42299/42332.html

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Brief Summary in Lay Language

DELIGHT (Delay of impaired glucose tolerance by a healthy lifestyle trial) is a study as to the feasibility to achieve sustainable prevention from diabetes mellitus type 2 in individuals at risk from German companies. Until the age of fifty approximately every second man or woman develops prediabetes in Germany, which means elevated blood sugar at the verge to diabetes. The involved metabolic changes double cardiovascular and total mortality and 5-10% of those individuals at risk will develop diabetes per year. Though several randomized clinical trials have proven that diabetes type 2 is evitable by moderate lifestyle modification, no screening for prediabetes has been implemented as yet. DELIGHT (Delay of impaired glucose tolerance by a healthy lifestyle trial) assesses if long-standing diabetes prevention is feasible within the financial scope of the German legal health system.
In 5 companies employees with a waist circumference of ≥94 cm (men) and ≥80 cm (women) were offered a check-up including anthropometry, fasting blood sugar and lipids, an oral sugar tolerance test, and questionnaires regarding life-style and nutrition. Those with fasting blood sugar ≥100 mg/dl or blood sugar in the oral sugar tolerance test after two hours ≥140 mg/dl were followed for 3 years and offered an optional moderate lifestyle intervention program including dietary advice and walking during the first year.
34% of 240 participants with elevated waist had impaired glucose tolerance (30-40 years 26%; >50 years 48%), 3% of these an as yet unknown diabetes. 95% were identified by fasting glucose ≥100 mg/dl. 60% of men and 45% of women were hypertensive; 50% had a metabolic syndrome. On average the mean weight of those that had lost ≥1 kg was 6 kg lower in men and 3 kg in women after 6 months and similarly after 3 years. Blood sugar, lipids such as cholesterol and blood pressure were improved. Among these no diabetes developed. Those 4 out of 8 with newly diagnosed diabetics who lost ≥1 kg also cured their diabetes. Among those with a weight loss of <1kg or weight gain, 10% of men and 5% of women developed diabetes type 2. A cost analysis indicated that screening for prediabetes does not lead to an increase in number or costs of drug prescriptions.
Thus screening for prediabetes and long-term diabetes prevention is successfully feasible within the scope of a legal insurance system. Cost do not rise, rather future savings seem plausible.

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Brief Summary in Scientific Language

DELIGHT (Delay of impaired glucose tolerance by a healthy lifestyle trial)
– A Feasibility Study on Sustainable Diabetes Prevention in Germany -
Until the age of fifty approximately every second man or woman develops prediabetes in Germany. This doubles cardiovascular and total mortality and 5-10% develop diabetes per year. Though several randomized trials have proven that diabetes type 2 is evitable by moderate lifestyle modification, no screening for prediabetes has been implemented as yet. DELIGHT (Delay of impaired glucose tolerance by a healthy lifestyle trial) assess if long-standing diabetes prevention is feasible within the financial scope of the German legal health system.
In 5 companies employees with a waist circumference of ≥94 (men) and ≥80 cm (women) were offered a check-up including anthropometry, fasting plasma glucose and lipids, an oral glucose tolerance test, and questionnaires regarding life-style and nutrition. Those with fasting plasma glucose ≥100 mg/dl or postprandially ≥140 mg/dl were followed for 3 years and offered an optional moderate lifestyle intervention program including dietary advice and walking during the first year.
34% of 240 participants with elevated waist had impaired glucose tolerance (30-40 years 26%; >50 years 48%), 3% of these an as yet unknown diabetes. 95% were identified by fasting glucose ≥100 mg/dl. 60% of men and 45% of women were hypertensive; 50% had a metabolic syndrome. On average the mean weight of those that had lost ≥1 kg was 6 kg lower in men and 3 kg in women after 6 months and similarly after 3 years. Plasma glucose, lipids and blood pressure were improved. Among these no diabetes developed. 4 out of 8 newly diagnosed diabetics lost ≥1 kg and their diabetes. Among those with a weight loss of <1kg or weight gain, 10% of men and 5% of women developed diabetes type 2. A cost analysis indicated that screening for prediabetes does not lead to an increase in number or costs of drug prescriptions.
Thus screening for prediabetes and long-term diabetes prevention is successfully feasible within the scope of a legal insurance system. Cost do not rise, rather future savings seem plausible.

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Organizational Data

  •   DRKS00000695
  •   2013/04/24
  •   [---]*
  •   yes
  •   Approved
  •   OB-068/04, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   I10.00 -  [generalization I10: Essential (primary) hypertension]
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Interventions/Observational Groups

  •   The voluntary intervention program consisted of sessions on nutrition or physical activity for up to 15 participants held by a certified dietician or a trainer, respectively, for 1.5 hours each. Initially, 6 sessions of dietary advice according to the Finnish Diabetes Prevention Program (Tuomilehto et al. 2001), changed every other week with 6 sessions on advice and motivation for physical activity including a walking program. During the following 6 months 6 sessions of advice were held by the dietician and the trainer, followed by 6 biweekly sessions each integrating a repetition of the contents of the dietary and training program. During the two following years combined sessions of 1.5 hrs by a dietician and a trainer were offered every 3 months. Every session provided the opportunity to measure the weight and discuss the behavioral consequences.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Preservation of or progress to diabetes mellitus type 2 within 3 years

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Secondary Outcome

Weight, waist circumference, blood pressure, lipid profile, quality of life (questionnaire), costs within 3 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2004/10/21
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Healthy women and men with a waist circumference of ≥80 cm or ≥94 cm, respectively, and fasting plasma glucose ≥100 mg/dl or plasma glucose ≥140 mg/dl two hours after an oral challenge with 75g glucose.

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Exclusion Criteria

Significant limitations as to nutrition like gastrointestinal or metabolic diseases or eating disorders, which do not allow to comply with the dietary recommendations, or significant limitations as to physical activity, particularly cardiovascular or orthopedic problems, which limit physical performance. A known diabetes mellitus known before screening excludes the participation.

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Addresses

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    • Präventive MedizinKlinik und Poliklinik für Allgemeine und Interventionelle Kardiologie - Universitäres Herzzentrum Hamburg - Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med.  Eberhard  Windler 
    • Martinistr. 52 N26
    • 20246  Hamburg
    • Germany
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    • Preventive Medicine and NutritionInstitute for Health Services Research in Dermatology and Nursing (IVDP)University Medical Center Hamburg-Eppendorf
    • Ms.  Dr. oec. troph.  Birgit-Christiane  Zyriax 
    • Martinistr. 52 N26
    • 20246  Hamburg
    • Germany
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    • Präventive MedizinKlinik und Poliklinik für Allgemeine und Interventionelle Kardiologie - Universitäres Herzzentrum Hamburg - Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Dr. oec. troph.  Birgit-Christiane  Zyriax 
    • Martinistr. 52 N36
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • AOK-Nordwest - Die Gesundheitskasse
    • Mr.  Bernd  Letsch 
    • Edisonstraße 70
    • 24145  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/10/20
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Trial Publications, Results and other Documents

  •   Association of cognitive dietary restraint and disinhibition with prediabetes--cross-sectional and longitudinal data of a feasibility study in German employees. Zyriax BC, Wolf C, Schlüter A, Khattak AH, Westenhoefer J, Windler E. Public Health Nutr. 2012 May;15(5):860-7 Zyriax BC, Letsch B, Stock S, Windler E. DELIGHT (Delay of impaired glucose tolerance by a healthy lifestyle trial) A Feasibility Study on Implementing a Program of Sustainable Diabetes Prevention in German Companies. Experimental and Clinical Endocrinology and Diabetes. 2013, im Druck Zyriax BC, Ramona Salazar R, Hoeppner W, Vettorazzi E, Christian Herder C, Windler E. The association of genetic markers for type 2 diabetes with prediabetic status - cross-sectional data of a diabetes prevention trial. Genetic markers for prediabets. PLoS One. 2013, im Druck
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* This entry means the parameter is not applicable or has not been set.