{
  "FullStudy":{
    "Rank":218018,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513798",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Dnr 2011-294-31M"
          },
          "Organization":{
            "OrgFullName":"Umeå University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial",
          "OfficialTitle":"Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 25, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 26, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Tommy Olsson",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Umeå University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Umeå University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. The investigators randomize 40 participants to two groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2) Modified paleolithic diet and general advice about exercise.\n\nThe investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes Mellitus, Type 2"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Diet Therapy",
              "Exercise Therapy",
              "Insulin Resistance"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Exercise under observation",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Modified paleolithic diet and exercise 3 sessions/week under observation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Modified paleolithic diet and exercise under observation"
                  ]
                }
              },{
                "ArmGroupLabel":"General advice on exercise",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Modified paleolithic diet and general advice on exercise",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Modified paleolithic diet and general advice on exercise"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Modified paleolithic diet and exercise under observation",
                "InterventionDescription":"Modified paleolithic diet and exercise 3 session/week under observation",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Exercise under observation"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Modified paleolithic diet and general advice on exercise",
                "InterventionDescription":"Modified paleolithic diet and general advice on exercise",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "General advice on exercise"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Fat mass",
                "PrimaryOutcomeDescription":"Measured with DEXA (dual energy x-ray absorptiometry)",
                "PrimaryOutcomeTimeFrame":"Baseline - 12 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Peripheral insulin sensitivity",
                "SecondaryOutcomeDescription":"Measured with euglycemic hyperinsulinemic clamp",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Hepatic insulin sensitivity",
                "SecondaryOutcomeDescription":"Measured with euglycemic hyperinsulinemic clamp",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Liver fat",
                "SecondaryOutcomeDescription":"Measured with 1H-MRS (proton magnetic resonance spectroscopy)",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Cortisol turnover",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Appetite regulation",
                "SecondaryOutcomeDescription":"GLP-1 (glucagon-like peptide 1), peptide YY",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Dopamine 2-receptors in striatum",
                "SecondaryOutcomeDescription":"PET",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Executive ability and memory",
                "SecondaryOutcomeDescription":"fMRI (functional magnetic resonance imaging)",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Experience of training",
                "SecondaryOutcomeDescription":"SCI ESES (Spinal Cord Injury Exercise Self-Efficacy Scale, ABC (Activities-specific Balance Confidence scale), PRETIE-Q (Preference for and Tolerance of the Intensity of Exercise Questionnaire)",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Validity of energy intake and protein intake",
                "SecondaryOutcomeDescription":"Actiheart®, food diary, weight, nitrogen excretion",
                "SecondaryOutcomeTimeFrame":"Baseline - 6 weeks - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Oxygen Uptake",
                "SecondaryOutcomeDescription":"Cardiopulmonary exercise testing",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Anaerobic Threshold",
                "SecondaryOutcomeDescription":"Cardiopulmonary exercise testing",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Substrate utilization during submaximal exercise",
                "SecondaryOutcomeDescription":"Measured with indirect calorimetry during ergometer cycling",
                "SecondaryOutcomeTimeFrame":"Baseline - 12 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ntype 2 diabetes less than 10 years\nBMI 27-35\nwomen only after menopause\ndiabetes treatment with diet and/or metformin\nHbA1c between 45 and 94\n\nExclusion Criteria:\n\nnicotine use\ninsulin\nbetablockers\nestrogens orally\nblod pressure >160/100\nmacroalbuminuria\nmalignancy during the past 5 years\nalcoholism\ndepression\ncardiovascular disease/stroke\nliver disease\nserious lung disease, GI disease or kidney disease\nmore than 30 minutes/5 days a week of moderate exercise during the last 6 months\nresistance training during the past 6 months\nofficial weight loosing program during the past year\nobesity surgery\nnight work\nMADRS-S (Montgomery Asberg Depression Rating Scale) >20 points\nAUDIT >14 points for women, >16 points for men\nnot possible to obtain venous sampling",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"30 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Tommy Olsson, Professor",
                "OverallOfficialAffiliation":"Department of Public Health and Clinical Medicine, Umeå University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Public Health and Clinical Medicine, Medicine",
                "LocationCity":"Umeå",
                "LocationZip":"90187",
                "LocationCountry":"Sweden"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"30652528",
                "ReferenceType":"derived",
                "ReferenceCitation":"Otten J, Andersson J, Ståhl J, Stomby A, Saleh A, Waling M, Ryberg M, Hauksson J, Svensson M, Johansson B, Olsson T. Exercise Training Adds Cardiometabolic Benefits of a Paleolithic Diet in Type 2 Diabetes Mellitus. J Am Heart Assoc. 2019 Jan 22;8(2):e010634. doi: 10.1161/JAHA.118.010634."
              },{
                "ReferencePMID":"29696296",
                "ReferenceType":"derived",
                "ReferenceCitation":"Otten J, Stomby A, Waling M, Isaksson A, Söderström I, Ryberg M, Svensson M, Hauksson J, Olsson T. A heterogeneous response of liver and skeletal muscle fat to the combination of a Paleolithic diet and exercise in obese individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2018 Jul;61(7):1548-1559. doi: 10.1007/s00125-018-4618-y. Epub 2018 Apr 26."
              },{
                "ReferencePMID":"29255413",
                "ReferenceType":"derived",
                "ReferenceCitation":"Stomby A, Otten J, Ryberg M, Nyberg L, Olsson T, Boraxbekk CJ. A Paleolithic Diet with and without Combined Aerobic and Resistance Exercise Increases Functional Brain Responses and Hippocampal Volume in Subjects with Type 2 Diabetes. Front Aging Neurosci. 2017 Dec 4;9:391. doi: 10.3389/fnagi.2017.00391. eCollection 2017."
              },{
                "ReferencePMID":"27235022",
                "ReferenceType":"derived",
                "ReferenceCitation":"Otten J, Stomby A, Waling M, Isaksson A, Tellström A, Lundin-Olsson L, Brage S, Ryberg M, Svensson M, Olsson T. Benefits of a Paleolithic diet with and without supervised exercise on fat mass, insulin sensitivity, and glycemic control: a randomized controlled trial in individuals with type 2 diabetes. Diabetes Metab Res Rev. 2017 Jan;33(1). doi: 10.1002/dmrr.2828. Epub 2016 Jun 30."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003920",
                "ConditionMeshTerm":"Diabetes Mellitus"
              },{
                "ConditionMeshId":"D000003924",
                "ConditionMeshTerm":"Diabetes Mellitus, Type 2"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000044882",
                "ConditionAncestorTerm":"Glucose Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5702",
                "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2",
                "ConditionBrowseLeafAsFound":"Diabetes Mellitus, Type 2",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafAsFound":"Diabetes",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8953",
                "ConditionBrowseLeafName":"Insulin Resistance",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23990",
                "ConditionBrowseLeafName":"Glucose Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}